{
  "version": 3,
  "sources": ["ssg:https://framerusercontent.com/modules/KNV1Ygj2cXFAcLwcW94h/28TPUTefrGipVM7UXLXP/bofJBXH2Y-3.js"],
  "sourcesContent": ["import{jsx as e,jsxs as t}from\"react/jsx-runtime\";import{Link as i}from\"framer\";import*as r from\"react\";export const richText=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:\"Regulatory Excellence encompasses the adherence to stringent guidelines, procedural accuracy, and strategic alignment necessary for navigating the complex landscape of compliance and approvals within the MedTech industry.\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"At its core, Regulatory Excellence involves meticulous attention to meeting and often surpassing the regulatory requirements set forth by governing bodies\"}),\". This extends from initial product conception to development, manufacturing, and eventual market launch. The quest for Regulatory Excellence isn't merely about ticking checkboxes; it's about ensuring the utmost safety, efficacy, and reliability of medical devices for the end users.\"]}),/*#__PURE__*/e(\"h2\",{children:\"Why has Regulatory Excellence gained such prominence?\"}),/*#__PURE__*/e(\"p\",{children:\"The answer lies in the new era of continuous regulatory change. With advancements in technology and an increased awareness of safety and efficacy, regulatory bodies worldwide are continuously refining and tightening their standards. Consequently, companies must excel in their regulatory processes to remain competitive and ensure their products meet or exceed these stringent criteria.\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"It's imperative for Regulatory Affairs to transition from being viewed as a bottleneck to becoming a crucial facilitator for business growth and an enabler of innovation\"}),\". This transition involves fostering a culture of compliance and continuous improvement within organizations. Companies that prioritize Regulatory Excellence integrate it into their ethos, driving innovation while ensuring a comprehensive understanding and taking a proactive approach to compliance.\"]}),/*#__PURE__*/e(\"h3\",{children:\"The consequences of overlooking Regulatory Excellence\"}),/*#__PURE__*/e(\"p\",{children:\"Regulatory hurdles, delays in approvals, or non-compliance issues can not only impact market entry but also tarnish a brand's reputation and significantly dent financial stability. In contrast, excelling in regulatory processes can confer a competitive advantage by streamlining market access and facilitating global expansion.\"}),/*#__PURE__*/t(\"h4\",{children:[/*#__PURE__*/e(\"br\",{}),\"Conclusion:\"]}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Regulatory Excellence has transcended being a \u201Cnice to have\u201D\"}),\".\\xa0 It's now a fundamental component of success in the medical devices industry. Companies that prioritize and invest in Regulatory Excellence fortify their position in a landscape where adherence to regulations isn't just a requirement but a pathway to innovation and sustained business growth.\"]}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"The Essenvia RIM Platform serves as a pivotal catalyst in achieving Regulatory Excellence\"}),\". Through the centralized and streamlined management of regulatory data and processes, our robust platform significantly heightens efficiency and precision in submissions and compliance.  The platform enables real-time tracking of regulatory changes, empowering proactive adjustments to strategies and submissions. Its comprehensive capabilities in consolidating information, managing documentation, and automating workflows not only diminish errors but also cultivate a culture of compliance and ongoing improvement within organizations.\"]}),/*#__PURE__*/t(\"p\",{children:[\"Do not hesitate to \",/*#__PURE__*/e(i,{href:{webPageId:\"OhudbEura\"},openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"book a personalized demo \"})}),\"of the Essenvia RIM Platform to discuss how it can enable MedTech companies to achieve regulatory excellence.\"]})]});export const richText1=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/t(\"p\",{children:[\"Different policies and submission procedures across countries and regions create a significant barrier to meeting regulatory deadlines and can easily become an intricate puzzle\",/*#__PURE__*/e(\"strong\",{children:\" if there is not a centralized Regulatory (RIM) Platform to merge and automate all regulatory processes and data\"}),\".\"]}),/*#__PURE__*/e(\"p\",{children:\"Beyond regulatory teams, RIM Platforms lead to cross-functional efficiency gains and catalyze company-wide benefits, especially in accelerating the time-to-market for new products.\"}),/*#__PURE__*/e(\"p\",{children:\"Employing a RIM Platform for regulatory management enhances efficiency, reduces the risk of rejection or noncompliance, and offers comprehensive visibility across global registration processes.  Beyond regulatory teams, RIM systems catalyze company-wide benefits, especially in expediting the time-to-market for new products.\"}),/*#__PURE__*/e(\"h2\",{children:\"#3 ways the Essenvia RIM Platform can accelerate time-to-market for new products\"}),/*#__PURE__*/e(\"p\",{children:\"Essenvia RIM Platform offers a suite of capabilities enabling MedTech companies to expedite market entry and sustain their presence:\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/t(\"strong\",{children:[\"#1. Digital Forms and Templates\",/*#__PURE__*/e(\"br\",{})]}),\"Essenvia offers a comprehensive library of expert-prepared templates for different products and markets and significantly reduces the time to submission.\"]}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/t(\"strong\",{children:[\"#2. Centralized Visibility\",/*#__PURE__*/e(\"br\",{})]}),\"Our Platform acts as a digital hub for regulatory data (providing a singular source of truth) and enables teams to reuse information across global applications and registrations, streamlining processes and improving visibility (including integration with eQMS, PLM, DMS or CRM).\"]}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/t(\"strong\",{children:[\"#3. Regulatory Intelligence\",/*#__PURE__*/e(\"br\",{})]}),\"The Essenvia RIM Platform provides proactive alerts on new or updated guidance and standards that are applicable to your products, offers information on competitor products, and real-time executive dashboards to review the internal status of submissions and time to completion.\"]}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"br\",{}),\"Do not hesitate to\",/*#__PURE__*/e(i,{href:{webPageId:\"OhudbEura\"},openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\" book a personalized demo \"})}),\"of the Essenvia RIM Platform to discuss your specific use cases and support your decision on whether it makes sense to adopt modern technology to streamline your regulatory work. \"]}),/*#__PURE__*/e(\"p\",{children:\"Our team of regulatory experts will consult with you about your specific organization's needs and provide an honest perspective on whether an RIM solution can support you.\"}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]});export const richText2=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:\"In the dynamic landscape of the MedTech industry, navigating global product registrations stands as a critical milestone for companies aiming to introduce innovative medical devices to diverse markets worldwide. Amidst the complexities of regulatory compliance, the adoption of Regulatory Information Management (RIM) technology emerges as a game-changer, revolutionizing the way MedTech companies approach and expedite global product registrations.\"}),/*#__PURE__*/e(\"p\",{children:\"So\u2026why use a Regulatory (RIM) Platform in Global Product Registrations?\"}),/*#__PURE__*/e(\"h2\",{children:\"Unified Data Management\"}),/*#__PURE__*/e(\"p\",{children:\"RIM technology serves as a centralized hub that consolidates and organizes crucial regulatory data, encompassing product details, submissions, compliance documents, and regulatory requirements. This centralization streamlines data accessibility, ensuring accuracy and consistency while minimizing redundancies across different regulatory frameworks.\"}),/*#__PURE__*/e(\"h2\",{children:\"Streamlined Regulatory Processes\"}),/*#__PURE__*/e(\"p\",{children:\"By automating workflows and standardizing procedures, RIM technology optimizes regulatory processes. From managing submissions to tracking approvals, the system facilitates a seamless flow of information, enhancing efficiency and expediting timelines.\"}),/*#__PURE__*/e(\"h2\",{children:\"Global Compliance and Adaptability\"}),/*#__PURE__*/e(\"p\",{children:\"Operating in multiple jurisdictions demands adherence to diverse regulatory standards. RIM technology aids in harmonizing data to comply with specific requirements of various regulatory authorities, ensuring that submissions meet the unique criteria of each market while swiftly adapting to evolving regulations.\"}),/*#__PURE__*/e(\"h2\",{children:\"Collaborative Efficiency\"}),/*#__PURE__*/e(\"p\",{children:\"RIM fosters enhanced collaboration among interdisciplinary teams involved in regulatory affairs, quality control, and product development. Real-time access to updated information promotes effective communication, enabling synchronized efforts toward meeting regulatory requirements across geographies.\"}),/*#__PURE__*/e(\"h2\",{children:\"Efficient Submission Management\"}),/*#__PURE__*/e(\"p\",{children:\"Submitting applications for product approvals across different countries requires meticulous coordination. RIM technology standardizes submission formats, reduces errors, and facilitates timely and accurate submissions, expediting the approval process and market entry.\"}),/*#__PURE__*/e(\"h2\",{children:\"Agility in Regulatory Adaptation\"}),/*#__PURE__*/e(\"p\",{children:\"The regulatory landscape is ever-evolving, necessitating swift adaptation to changes. RIM equipped with tracking and monitoring functionalities empowers MedTech companies to stay informed about regulatory updates, facilitating prompt adjustments to maintain compliance across markets.\"}),/*#__PURE__*/e(\"h2\",{children:\"Future Prospects and Challenges\"}),/*#__PURE__*/e(\"p\",{children:\"While RIM technology holds immense promise for streamlining global product registrations, challenges persist. Legacy system integration, data standardization, and cybersecurity concerns require continual attention. However, ongoing technological advancements and collaborative efforts within the industry aim to overcome these obstacles, paving the way for more seamless global registrations.\"}),/*#__PURE__*/e(\"h3\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})}),/*#__PURE__*/e(\"h3\",{children:\"Conclusion:\"}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"strong\",{children:\"Relying on color-coded spreadsheets to manage your device registrations and certificates is no longer viable!\"})}),/*#__PURE__*/t(\"p\",{children:[\"In the MedTech domain, RIM technology emerges as a pivotal tool, enabling companies to navigate the intricate maze of global product registrations. Its ability to centralize data, streamline processes, and foster collaboration \",/*#__PURE__*/e(\"strong\",{children:\"positions it as a cornerstone for MedTech companies seeking to attain swift market access while ensuring compliance across diverse regulatory landscapes\"}),\".\"]}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"RIM stands not just as a technological solution but as an enabler of progress\"}),\", facilitating the convergence of innovation, compliance, and global accessibility in the MedTech sphere. Embracing RIM is not merely adopting a system but embracing a pathway toward shaping the future of global healthcare accessibility.\"]}),/*#__PURE__*/t(\"p\",{children:[\"Know more about how the \",/*#__PURE__*/e(i,{href:{webPageId:\"pkCFtrOGK\"},openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"Essenvia RIM Platform\"})}),\" is making it easier to manage your medical device registrations globally.\"]})]});export const richText3=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:\"Navigating regulatory implications when making changes to medical devices is critical to ensuring compliance and market readiness. The evolving landscape demands a keen understanding of regulatory processes, especially in the United States, where the FDA oversees market entry through rigorous evaluations.\"}),/*#__PURE__*/e(\"h2\",{children:\"Assessing Regulatory Impact\"}),/*#__PURE__*/e(\"p\",{children:\"Once the risks associated with a proposed change are assessed, it's pivotal to reexamine its regulatory implications. In the U.S., the nature of the change often determines whether a new premarket notification, commonly known as a 510(k), must be submitted to the FDA for review and clearance before the device can legally enter the market.\"}),/*#__PURE__*/e(\"p\",{children:\"Understanding the classification of your medical device is essential. Refamiliarizing yourself with classification-specific requirements provides a foundation for gauging the potential regulatory impact of the proposed change. The FDA offers comprehensive guidance documents that aid in adopting a risk-based approach to assess the necessity of a 510(k) submission for alterations to an existing device.\"}),/*#__PURE__*/e(\"h2\",{children:\"Proactive Steps for Compliance\"}),/*#__PURE__*/e(\"p\",{children:\"Being prepared to move forward with a change involves proactive measures. If a 510(k) submission is necessary, initiating the process early is advisable. Contacting the FDA and submitting the required form well in advance allows ample time for review and collaboration. Engaging with regulatory authorities before implementing the change helps navigate potential regulatory hurdles and prevents setbacks after investing resources in the change's implementation.\"}),/*#__PURE__*/e(\"h2\",{children:\"Navigating the Complexity\"}),/*#__PURE__*/e(\"p\",{children:\"The regulatory implications of changes in medical devices are multifaceted. The intricacies of the FDA's review process necessitate proactive engagement and a comprehensive understanding of the regulatory landscape. Timely and informed action, coupled with a proactive approach to compliance, can streamline the process and mitigate regulatory challenges.\"}),/*#__PURE__*/e(\"h3\",{children:\"Conclusion:\"}),/*#__PURE__*/t(\"p\",{children:[\"In the realm of medical devices, regulatory compliance is the cornerstone of market entry and product success. Adhering to regulatory requirements, particularly when implementing changes, demands careful consideration and proactive engagement with regulatory bodies. By proactively assessing and addressing regulatory implications, medical device companies can navigate changes effectively, ensuring compliance and facilitating successful market entry for innovative products. \",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{}),\"With a specific platform module dedicated to change management, the \",/*#__PURE__*/e(i,{href:{webPageId:\"pkCFtrOGK\"},openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"Essenvia RIM Platform\"})}),\" allows you to easily manage change control workflows and streamline collaboration with regulatory teams, including powerful capabilities such as:\"]}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Automate Regulatory Change assessment\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Determine the impact of change (significant or insignificant)\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Automate creation of Letter to file / memo to file\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Project management across changes from initial assessment to closure\"})})]}),/*#__PURE__*/t(\"p\",{children:[\"Do not hesitate to \",/*#__PURE__*/e(i,{href:{webPageId:\"OhudbEura\"},openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"book a personalized demo\"})}),\".\"]})]});export const richText4=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:\"For regulatory teams navigating the ever-evolving landscape of the MedTech industry, a Regulatory Intelligence platform isn't just a \u201Cnice to have\u201D \u2014it's an absolute necessity!\\xa0\"}),/*#__PURE__*/e(\"p\",{children:\"Let's explore why MedTech regulatory teams shouldn't operate without the guiding light of regulatory intelligence.\"}),/*#__PURE__*/e(\"h2\",{children:\"Staying Ahead of Regulatory Changes\"}),/*#__PURE__*/e(\"p\",{children:\"The medical device sector operates within a dynamic framework of global regulations. Without a robust regulatory intelligence tool, teams find themselves playing catch-up with the rapidly shifting regulatory landscape. Staying updated becomes a formidable challenge, leaving regulatory teams susceptible to compliance gaps or oversights.\"}),/*#__PURE__*/e(\"h3\",{children:\"Solving the Research Puzzle\"}),/*#__PURE__*/e(\"p\",{children:\"Navigating diverse regulatory requirements across various countries consumes an immense amount of time and resources. A lack of regulatory intelligence means regulatory teams spend substantial effort researching, collating, and deciphering these intricate requirements manually. Consequently, precious time that could be dedicated to strategic initiatives is lost in the labyrinth of regulatory research.\"}),/*#__PURE__*/e(\"h3\",{children:\"Resolving the Conflict of Information\"}),/*#__PURE__*/e(\"p\",{children:\"Regional partners might provide conflicting regulatory insights or guidelines, leading to confusion and inefficiencies within regulatory operations. A reliable regulatory intelligence platform serves as a single source of truth, aligning disparate information streams and ensuring consistency in compliance strategies across regions.\"}),/*#__PURE__*/e(\"h3\",{children:\"Engaging Proactively with Regulatory Changes\"}),/*#__PURE__*/e(\"p\",{children:\"Participation in industry feedback loops on draft regulations or guidance is pivotal for MedTech companies. Without regulatory intelligence, teams might miss these crucial opportunities, impacting their ability to influence or adapt to forthcoming regulatory amendments effectively.\"}),/*#__PURE__*/e(\"h3\",{children:\"From Reaction to Proactive Preparedness\"}),/*#__PURE__*/e(\"p\",{children:\"A reactive stance toward new regulations can create chaos within regulatory teams. Insufficient notice or untimely access to necessary information prevents their ability to respond effectively. Regulatory intelligence empowers teams to anticipate changes and improve predictability on regulatory requirements and timelines\"}),/*#__PURE__*/e(\"h4\",{children:\"Conclusion:\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Without reliable Regulatory Intelligence, teams become vulnerable to regulatory pitfalls\"}),\", compromise their ability to navigate complexities efficiently, and stifle their proactive engagement within the evolving regulatory landscape. \",/*#__PURE__*/e(\"strong\",{children:\"Regulatory intelligence isn't a luxury\"}),\"; it's an imperative investment for MedTech RA teams striving for regulatory excellence and sustainable growth.\"]}),/*#__PURE__*/t(\"p\",{children:[\"Know more about how \",/*#__PURE__*/e(i,{href:{webPageId:\"OhudbEura\"},openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"Essenvia RIM Platform \"})}),\"provides RA teams with comprehensive regulatory intelligence, including monitoring competitors\\xb4 products\\xa0 and target markets and getting frequent updates on the regulations, guidance documents, and news that directly impact your medical devices and your business.\"]})]});export const richText5=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:\"Class III PMA (pre-market approval) has a lot to offer for companies. In addition to getting clear approval for a device, Class III PMA also offers product protections similar in many respects to a patent, making it highly desirable. That being said, it\u2019s also a complex and challenging regulatory pathway to navigate, leading many industry leaders to pursue simpler, but less-rewarding approval options.\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Perhaps the biggest challenge with Class III PMA is the need to balance speed with quality\"}),\". When companies aren\u2019t prepared for the process, they can be overwhelmed with the FDA\u2019s requirements and left uncertain about their chances of getting their device approved in a timely manner. This discourages companies from pursuing a Class III PMA despite its many advantages.\"]}),/*#__PURE__*/e(\"p\",{children:\"Another major point of uncertainty is how to classify a particular product. Different classes of products have different reimbursement levels, and getting a product classified incorrectly can leave companies with manufacturing and distribution costs that far outweigh the expected returns. Many companies may not even know if a device needs PMA at all. This is based heavily on how the FDA chose to classify similar products in the past, so having a clear understanding of the FDA\u2019s body of regulatory work is essential.\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"The regulatory landscape has shifted significantly in recent years\"}),\". PMA was originally designed to be the pathway of choice for all new products coming on the market, while the 510(k) was intended to serve as a streamlined pathway for modifications to existing products. Submission numbers make it clear that far more manufacturers are taking the 510(k) route these days, despite the advantages that PMA offers.\"]}),/*#__PURE__*/t(\"p\",{children:[\"This shifting landscape has left many industry leaders with the misconception that 510(k) and PMA are substantially equivalent options, which in turn leaves them unprepared for the rigors of the PMA approach when they choose to pursue it. \",/*#__PURE__*/e(\"strong\",{children:\"The key advantage of PMA over 510(k) is that a device that gets PMA retains it for all future versions of that device, unless it gets down-classified\"}),\". This means that manufacturers can go through the regulatory approval process just once, and have approval and protections for a whole line of similar devices.\"]}),/*#__PURE__*/e(\"p\",{children:\"The first step for any regulatory approval process, whether 510(k) or PMA, is a comprehensive evaluation of the product and the regulatory framework. This evaluation needs to include risk-based classification options, highly detailed comparison to existing products, careful scrutiny of real-world device performance, well-selected effectiveness criteria, and a clear understanding of user fees.\"}),/*#__PURE__*/e(\"p\",{children:\"The bottom line here is that PMA offers much more in the way of product protections than 510(k) approval, but it also requires manufacturers to go through a much more complex and rigorous approval process. Companies need to weigh these considerations carefully to make the best possible decisions not just for getting their products to market quickly, but for setting their products up for long-term success and profitability.\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Technology and Modern Regulatory Platforms offer a beacon of hope to manufacturers here\"}),\". They contain powerful capabilities to guide companies through the Class III PMA landscape, including:\"]}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Streamlining Regulatory Processes\"}),/*#__PURE__*/e(\"br\",{}),\"Good regulatory platforms can do a lot to untangle confusing regulatory processes by including meticulous documentation, version tracking, and automatic compliance with FDA guidelines.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Data-Driven Decision Making\"}),/*#__PURE__*/e(\"br\",{}),\"By harnessing big data and analytics, regulatory platforms can empower companies to make informed decisions about device performance and classification based on internal testing and FDA records.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"12px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Global Collaboration\"}),/*#__PURE__*/e(\"br\",{}),\"Regulatory platforms make it easy for teams working in multiple time zones and even multiple countries to work effectively and efficiently together, greatly accelerating the application process.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"12px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"AI and Machine Learning\"}),/*#__PURE__*/e(\"br\",{}),\"Machine learning algorithms can optimize product development by getting a head start on risk assessment, predictive modeling, and regulatory compliance.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Optimized Product Lifecycle Management\"}),/*#__PURE__*/e(\"br\",{}),\"Product lifecycle management tools allow companies to efficiently service their products throughout multiple versions, ensuring alignment with regulatory requirements from the initial concept stage throughout the post-market surveillance process.\"]})})]}),/*#__PURE__*/t(\"p\",{children:[\"The medical device industry continues to push for more innovation, and technology has emerged as a vital ally in the fight to quickly bring new products to market and comply with ever-changing regulations, especially those of the intricate Class III PMA pathway. \",/*#__PURE__*/e(\"strong\",{children:\"Companies that embrace these technological advancements will be empowered to navigate complexities, foster innovation, and prioritize patient safety and compliance.\"})]})]});export const richText6=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/t(\"ol\",{children:[/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Check eligibility of your 510(k)Submission\"}),\" by referring to the Electronic Submission Template or Medical Device 510(k) Submissions FDA Guidance.\"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Download the most up-to-date eSTAR PDF template\"}),\" from the FDA website.\"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Follow the embedded instructions in the eSTAR template\"}),\" structure and fill in the required information about the subject device. \"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Attach all the necessary documents\"}),\" like device description, mechanical test reports, biocompatibility reports, clinical data, and draft labeling into the eSTAR Template.\"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[\"To ensure file size and format compliance, combine attachments of each section to reduce separate files. A general recommendation would be \",/*#__PURE__*/e(\"strong\",{children:\"to compress all the PDF attachments to meet the 4 GB limit\"}),\", compatible image/video formats for the eSTAR Template.\"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Fill out required forms\"}),\" for eg: Truthful & Accurate statement (Form 3514), 510(k)Summary, Declaration of Conformity, and the Indications for Use (Form 3881) within the eSTAR template.\"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[\"After you have entered all the information and attachments in your eSTAR submission, \",/*#__PURE__*/e(\"strong\",{children:'the status message at the top will indicate \"eSTAR Complete.\"'}),' If you submit your eSTAR submission while the status message still indicates \"eSTAR Incomplete,\" the FDA may put your eSTAR submission on \"eCopy Hold.\"']}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Save a local copy of the completed eSTAR PDF\"}),\" and submit electronically based on device type (CDRH or CBER). For CDRH, send eSTAR premarket submissions online through the CDRH Portal or by mail to the appropriate address.\"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[\"All 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR through the \",/*#__PURE__*/e(\"strong\",{children:\"CDRH Portal for CDRH or the Electronic Submission Gateway (ESG) for CBER\"}),\".\"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[\"After submission, the FDA will conduct a technical screening of the eSTAR 510(k) submission and update the status to \",/*#__PURE__*/e(\"strong\",{children:\"\u201CTSOK\u201D - Technical Screening OK or \u201CTSIC\u201D - Technical Screening Incomplete\"}),\" and is put on an early Technical Screening hold for 180 days, until a complete replacement eSTAR is submitted.\"]})})]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})}),/*#__PURE__*/e(\"img\",{alt:\"\",className:\"framer-image\",\"data-framer-asset\":\"data:framer/asset-reference,OChaZYAjbox1bQTA8Nrwp9F7Qmw.jpg\",\"data-framer-height\":\"2227\",\"data-framer-width\":\"1600\",height:\"1113\",src:\"https://framerusercontent.com/images/OChaZYAjbox1bQTA8Nrwp9F7Qmw.jpg\",style:{aspectRatio:\"1600 / 2227\"},width:\"800\"})]});export const richText7=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"h2\",{children:\"Overview\"}),/*#__PURE__*/e(\"p\",{children:\"Asking the right questions during pre-submission or Q-submission is essential for manufacturers who want to get effective feedback from the U.S. Food and Drug Administration (FDA). Failure to ask the right questions will set companies up for at least two more rounds of back-and-forth, since they won\u2019t even know what they don\u2019t know yet. Thoroughly reviewing the FDA\u2019s documentation of their Q-submission program is essential, as is anticipating the kinds of issues that a specific product will face in getting through the regulatory process. Failure to prepare in this way is going to lead to a much longer and more costly review process.\"}),/*#__PURE__*/e(\"p\",{children:\"When used correctly, the Q-submission process allows companies to figure out exactly what type of information they need to submit to the FDA for final approval, as well as any changes that may need to be made to the final product design. This in turn can speed up the whole product development process, allowing companies to get products to market more quickly. This all comes down to asking the right questions.\"}),/*#__PURE__*/e(\"p\",{children:\"The FDA\u2019s pre-submission program is especially useful with, for example, medical devices on in-vitro diagnostics. As long as you ask the right questions, the FDA will give you the feedback you need to speed up the approval process.\"}),/*#__PURE__*/e(\"p\",{children:\"The FDA offers feedback on proposed bench, pre-clinical, and clinical programs, and this feedback is key to choosing the best regulatory strategy for each product. FDA feedback can also include useful predicate devices to consider, allowing manufacturers to choose the best comparable product to their own.\"}),/*#__PURE__*/e(\"h2\",{children:\"Common Mistakes to Avoid\"}),/*#__PURE__*/e(\"p\",{children:\"It\u2019s important for companies to take the Pre-Sub program seriously. This isn\u2019t just a nice way to get some information in advance, or a trial run. Mistakes in the pre-sub process, most often because of poorly thought-out questions, will lead to lengthy delays and even to rejection of products altogether. It\u2019s important to remember that direct contact with the FDA\u2019s regulators is especially valuable; it can take them a long time to get back around to your product if you have follow-up questions to ask or need to reformulate some questions.\"}),/*#__PURE__*/e(\"p\",{children:\"Manufacturers that submit incomplete or incorrect descriptions of their products, vague details about how products function, or data that fails to demonstrate the key features of their products are going to have a hard time getting effective feedback from the FDA.\"}),/*#__PURE__*/e(\"h2\",{children:\"Sample Pre-Submission Questionnaire\"}),/*#__PURE__*/e(\"p\",{children:\"When submitting your device to the FDA, one of the first and most important steps is to provide detailed information about your device, including its history, available data on its use, and any concerns you\u2019re aware of or anticipating. Companies also need to review past development programs and use them as a model for developing their own regulatory strategy. Consider the following examples of bad questions\u2013and better versions of them.\"}),/*#__PURE__*/t(\"ol\",{children:[/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Poorly-formatted question:\"}),\" Are the proposed biocompatibility studies sufficient to support the clinical trials?\"]}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Improved question:\"}),\" \",/*#__PURE__*/e(\"em\",{children:\"It is clearly stated that the biocompatibility testing for the device will follow the recommended protocol that is used for devices with limited blood contact. The design team will use industry-standard materials for the device. The team will follow the standard manufacturing process. Therefore, there is no need for carcinogenicity testing. I would appreciate hearing the FDA\u2019s perspective on this issue.\"})]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Explanation:\"}),\" The initial question clearly reflects what the design team needs to know, but it doesn\u2019t offer any context or explanation to guide the FDA\u2019s understanding. The improved question clearly references what kind of testing protocol the device will follow, and offers a line of reasoning for why it\u2019s sufficient. The phrasing of the question also suggests confidence. All of this will make it easier for the FDA to correctly answer the question.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]})})]})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Poorly-formatted question:\"}),\" Would the FDA consider this device suitable for the De Novo pathway?\"]}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Improved question:\"}),\" \",/*#__PURE__*/e(\"em\",{children:\"We investigated the FDA database extensively but found no current predicates for our device. Nonetheless, our product is made of low-risk ordinary materials like water and salts. As a result, it qualifies for a De Novo request. Our product has been proven to be biocompatible. Furthermore, the earliest Good Laboratory Practices (GLP) reports have demonstrated its safety. Again, scientific trials involving over 2,000 patients have proved that our technology is safe and effective. Given the supporting evidence, we\u2019d like to know if the FDA agrees that a De Novo submission is the best regulatory route.\"})]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Explanation:\"}),\" Again, the improved question provides abundant context and persuasively makes an argument for the De Novo pathway. It\u2019s not simply asking the FDA for an answer; it\u2019s making an argument.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]})})]})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Poorly-formatted question: \"}),\"Can this device be used for the De Novo pathway as per FDA guidelines?\"]}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Improved question:\"}),\" \",/*#__PURE__*/e(\"em\",{children:\"A primary predicate device shows how the Alpha Graft is substantially equivalent to the predicate. Alpha Graft was chosen as the primary predicate based on its indication for use and technology (absorption over time). We have also proven that this device is the same as other 510(k)-approved devices that use the same technology or have the same usage. The Alpha Graft is compared and contrasted with already cleared graft material in Section 3 of the Pre-Submission form. We think that the material is an appropriate predicate. Are there any other suggestions for a predicate device that the FDA may have?\"})]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Explanation:\"}),\" The format of this question includes clear reference to a proposed predicate device. Choosing the correct predicate device is one of the most important steps in getting 510(k) approval, so walking the FDA through your thinking on this particular question is always a good idea. Note that the initial question doesn\u2019t even mention a predicate device. An FDA regulator would have a hard time determining the correct context for answering this question.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]})})]})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Poorly-formatted question:\"}),\" Does the FDA agree with the proposed Modular Pre-Market Approval (PMA) strategy?\"]}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Improved question:\"}),\" \",/*#__PURE__*/e(\"em\",{children:\"Section 5 of the Pre-Submission packet states that we plan to submit N (specify the number) of PMA modules. The first module, due in January 2024, will contain pre-clinical testing results, including biocompatibility, sterilization, and bench testing.The second module will include manufacturing information.Section 6 of the Pre-Submission packet states that the third module will contain literature, U.S. data, and OUS data.We will use literature to support the device\u2019s application to individuals over 85 years old. The U.S. and OUS data were collected using the same protocols and criteria as the predicate device. The data will be presented per the IDE Number. We will also provide sales and complaint data, as the device has been commercially available in Canada since 2017. Do you agree with this approach for module three, FDA?\"})]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Explanation:\"}),\" This question serves to guide FDA regulators through the documentation being submitted, and clearly demonstrates that the manufacturer has made good progress towards submitting everything they need for full approval. Again, this helps the regulators understand the question more clearly, and also demonstrates that this is a serious, well-researched submission.\"]})})]})]})]}),/*#__PURE__*/e(\"h2\",{children:\"Final Thoughts\"}),/*#__PURE__*/e(\"p\",{children:\"When manufacturers submit clear, well-thought-out questions that guide FDA regulators though their thinking, they can get clear, accurate, actionable feedback in return. Rushing through the Pre-Q process when important planning and research have yet to be completed will ultimately waste the time of manufacturers and the FDA.\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(i,{href:{webPageId:\"pkCFtrOGK\"},openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"Essenvia\"})}),\" is the Leading Platform to Simplify and Accelerate MedTech Regulatory Submissions, and currently the only system on the planet with a native eSTAR submission builder that allows collaboration and automation, often leading to faster submissions and quicker product approvals.\"]}),/*#__PURE__*/t(\"p\",{children:[\"To learn more about the Essenvia Submissions Platform \",/*#__PURE__*/e(i,{href:{webPageId:\"OhudbEura\"},openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"book a quick demo here.\"})}),/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]})]});export const richText8=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:\"The RAPS Convergence 2023, held in Montreal, went incredibly well. The event was perfectly organized, and industry experts had essential knowledge to share. One hot topic that got attention in multiple sessions was eSTAR, which is sensible given the system\u2019s required use in medical device submissions.\"}),/*#__PURE__*/e(\"p\",{children:\"Dr. Patrick Axtell, representing the FDA, gave a remote presentation that provided a deep dive into the details of \u201CThe eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions.\u201D Another essential talk came from Dr. Dhitri Roy of Essenvia, who guided attendees through the steps involved in transitioning to the now-mandatory 501(k) eSTAR submission process. Both of these sessions, as well as others on the topic, provided essential information to manufacturers, regulators, and marketers on this new process.\"}),/*#__PURE__*/e(\"h2\",{children:\"Deciphering the eSTAR Program with Dr. Axtell\"}),/*#__PURE__*/e(\"p\",{children:'Dr. Axtell\u2019s opening line gave a clear definition of the eSTAR: \"The eSTAR is a dynamic PDF template that guides applicants through the process of constructing their medical device submission.\u201D This is certainly true, but doesn\u2019t get at the real implications of the system. The eSTAR template is highly automated, taking the guesswork out of completing submissions before sending them to the FDA and helping manufacturers avoid long and costly RTA holds. The eSTAR template was made by the FDA and reflects their internal process for 510(k) submissions, as Dr. Axtell explained: \"The content and logic of eSTAR complements our internal review templates for 510(k)s, de novos, and pre-submissions.\"'}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"code\",{children:/*#__PURE__*/e(\"em\",{children:'\"The automation in eSTAR will automatically verify that eSTAR is complete, and therefore your review is not done with eSTARs, and your eSTAR cannot be put on an RTA hold.\"'})})}),/*#__PURE__*/e(\"h3\",{children:\"Submitting With the CDRH Portal\"}),/*#__PURE__*/e(\"p\",{children:\"Another key element in the eSTAR system is the CDRH portal. Dr. Axtell reviewed its key functions: This is the portal through which eSTAR templates are submitted, and it also detects incomplete eSTAR submissions, halt the submission process, and notify the user, which in turn \u201C...prevents things like downstream hold letters and hassle.\u201D\"}),/*#__PURE__*/e(\"h3\",{children:\"Navigating the eSTAR Website\"}),/*#__PURE__*/e(\"p\",{children:'People looking to explore the eSTAR program should start with a simple Google search for \u201CFDA eSTAR.\u201D This will quickly bring them to the FDA\u2019s official eSTAR website. One thing Dr. Axtell made clear is that submission teams should take the time to read the entire website. It has extensive instructions and a constantly-growing FAQ page and \"The vast majority of questions we get are addressed on that website.\"'}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"strong\",{children:\"The FDA\u2019s eSTAR website features links to the three types of eSTAR templates:\"})}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Non in-vitro diagnostics.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"In-vitro diagnostics.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:'Early submission requests (nicknamed \"pre-Star\").'})})]}),/*#__PURE__*/e(\"p\",{children:\"Dr. Axtell emphasized the importance of downloading the correct eSTAR template: \\\"If you don't download the right eSTAR, it'll eventually tell you that you did download the wrong one.\\\"\"}),/*#__PURE__*/e(\"h3\",{children:\"Common Technical Problems\"}),/*#__PURE__*/e(\"p\",{children:\"Dr. Axtell mentioned one common bug affecting eSTAR templates that are opened with the Windows-only version of Adobe Acrobat Pro. This bug doesn\u2019t affect 100% of templates, but it can lead to a delay when answering dropdowns or radio buttons in dynamic PDFs like eSTAR.\"}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"code\",{children:/*#__PURE__*/e(\"em\",{children:'\"Our center for Drugs is having an issue with it with their dynamic PDFs. But this bug does not affect any Mac versions of Adobe Acrobat Pro.\"'})})}),/*#__PURE__*/e(\"p\",{children:\"Because eSTAR functions as a standalone package that doesn\u2019t communicate with external systems, the PDF reader is one of the only possible sources of bugs with the template. It\u2019s also a good idea to review the extensive FAQ on the first page of the eSTAR template itself. This page contains the template\u2019s version history including changes applied at different points, as well as answering common questions.\"}),/*#__PURE__*/e(\"h3\",{children:\"Completing the eSTAR\"}),/*#__PURE__*/e(\"p\",{children:'The first part of the eSTAR template that users can directly fill out is a page for specifying the nature of their submission. Dr. Axtell made it clear that accuracy here is essential: \"Be sure you answer these questions accurately because different sections in the eSTAR will either show or hide based on your choices.\" In other words, incorrect information on the first page will make it impossible to find and fill out necessary sections for your device later in the process. Another key feature to be aware of is that eSTAR has color-coded indicators: Red sections must be completed, gray sections are optional, and green sections have been completed.'}),/*#__PURE__*/e(\"h3\",{children:\"Useful Features\"}),/*#__PURE__*/e(\"p\",{children:\"The blue question mark buttons throughout the template provide additional information about each section, which could include links to examples or images. It\u2019s always a good idea to review this information before proceeding with a given section.\"}),/*#__PURE__*/e(\"p\",{children:'The eSTAR template also has the ability to detect inconsistencies between sections, such as using different device names or specifications in different parts of the template. \"If it sees some inconsistencies, you\\'ll get a pop-up message advising you,\" Dr. Axtell explained.'}),/*#__PURE__*/e(\"p\",{children:\"To conclude, Dr. Axtell emphasized the FDA\u2019s long-term vision for eSTAR, focusing on a streamlined submission process that gets devices to market more quickly.\"}),/*#__PURE__*/e(\"h4\",{children:\"9 Key Takeaways from Dr. Patrick Axtell\u2019s eSTAR Presentation\"}),/*#__PURE__*/t(\"ol\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"The Technical Screening Process:\"}),\" This process is optional, but it\u2019s also the best way to make sure that all eSTAR responses are accurate and relevant. In addition to the technical review process, reviewers will manually inspect the submitted eSTAR template and all of its menus and attachments.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Checklists and Guidance:\"}),\" The technical screening process doesn\u2019t have a clear checklist or specific guidance. The acceptance of an eSTAR submission comes down to the manufacturer\u2019s correct use of the eSTAR template and the reviewer\u2019s judgment about the accuracy and relevance of the information being submitted.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Accuracy is Important:\"}),\" Especially in the early sections of the template, accuracy is incredibly important, since incorrect information at this point will deactivate important sections later in the document, leading to incomplete submissions and costly delays.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Attachments Should be Relevant:\"}),\" Part of the FDA reviewer\u2019s job is to check the relevancy and accuracy of any attachments, making sure that submissions contain at least one attachment document for each required attachment question. It should be noted that extraneous attachments, like blank documents or foreign-language versions of the same information will not hamper the technical review process as long as there is at least one relevant document included.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Responding to Additional Information Requests:\"}),\" If manufacturers are faced with requests for additional information, one thing they don\u2019t have to do is duplicate their original efforts with the latest version of the eSTAR template. They can simply make edits and additions to their original submission, as long as they used the most up-to-date version at the time of their initial submission.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"How to Provide Additional Information:\"}),\" Manufacturers have two options for providing additional information: They can edit and add attachments to their initial eSTAR submission, or send the requested attachments and information in an eCopy without using eSTAR.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Attachment File Types:\"}),\" While eSTAR will accept many file types, including PDFs, word documents, excel files, and videos, it will not allow the attachment of some files. Notably, submissions cannot include executable files, macro-enabled documents, or archive file types.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"eSTAR Deployment Timeline:\"}),\" The FDA has a clear order in which they are planning to enable other types of content in eSTAR. They\u2019re working to enable PMA content, 513g content, developing an internal IDE Smart review template, adding more Q subtypes, and completing the availability of IDE supplement types.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(0, 0, 0)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Health Canada Pilot Program:\"}),\" The FDA is currently working with Health Canada on a pilot program to test the feasibility of class three and four submissions, PMA contents, and using a single eSTAR submission for multiple regions. The FDA is collecting feedback and conducting surveys with participants to identify necessary changes and improvements to allow for this international rollout.\"]})})]}),/*#__PURE__*/e(\"h2\",{children:\"Dr. Dhriti Roy Guides us Across the eSTAR Gap\"}),/*#__PURE__*/e(\"p\",{children:\"Dr. Dhriti Roy of Essenvia gave a packed and well-received presentation: \u201CCrossing the eSTAR Chasm: How to Transition to FDA\u2019s Mandatory 510K eSTAR Submission Process.\u201D Her extensive experience in regulatory affairs made her the perfect person to highlight the importance of the FDA\u2019s eSTAR submission process, which became mandatory on October 1.\"}),/*#__PURE__*/e(\"h3\",{children:\"The Transition to eSTAR Submissions\"}),/*#__PURE__*/e(\"p\",{children:'The obvious reason for Dr. Roy\u2019s presentation, which she emphasized throughout, was the mandatory shift to eSTAR submissions starting on October 1. She started by explaining what exactly the eSTAR is: \"eSTAR is an interactive PDF for 510K submissions. FDA created this template to enhance consistency and efficiency in the preparation and review of 510K submissions.\" Like Dr. Axtell, she mentioned that the eSTAR does not go through the RTA process, but it does go through virus scanning and technical screening.'}),/*#__PURE__*/e(\"h3\",{children:\"The Historical Roots of eSTAR\"}),/*#__PURE__*/e(\"p\",{children:'The origins of eSTAR can be traced back to 1998, when the federal government started working to improve the electronic submission process for 510K submissions. \"Several government acts and initiatives have been introduced to streamline and improve the electronic submission process for 510K,\" Dr. Roy explained, all of which have culminated in the October 1 eSTAR mandate.'}),/*#__PURE__*/e(\"h3\",{children:\"eSTAR\u2019s Advantages and Limitations\"}),/*#__PURE__*/e(\"p\",{children:'The eSTAR represents an undeniable step forward in streamlining the 510K submission process. It will be faster, easier to use, and less expensive, both for manufactures and for the FDA. Dr. Roy knows this firsthand. \"To my personal experience, eSTAR provides a standard interactive PDF that makes sections better organized and more complete in comparison to eCopy Program.\" That being said, there are definitely some challenges with the existing process.'}),/*#__PURE__*/e(\"p\",{children:'The real issue here is that, while eSTAR and eCopy have a lot in common in terms of how documents get to the FDA, eSTAR essentially demands that manufacturers follow its process. This is going to require new tools and serious reorganization for many firms. \"It\\'s a significant change. You need to understand the process changes. Do you foresee the new impact?\" explained Dr. Roy.'}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"code\",{children:/*#__PURE__*/e(\"em\",{children:'\"Success in adapting depends on preparation. Have you asked yourself if you require the necessary infrastructure?\"'})})}),/*#__PURE__*/e(\"h3\",{children:\"eSTAR Transition Best Practices\"}),/*#__PURE__*/e(\"p\",{children:\"Dr. Roy\u2019s extensive experience meant that she had plenty of practical advice on how to navigate the move to eSTAR. She demonstrated up-to-date knowledge of existing bugs like the Adobe Acrobat Pro issue as well as detailed tips for navigating each section and menu in the eSTAR PDF.\"}),/*#__PURE__*/e(\"p\",{children:'Dr. Roy also emphasized the importance of developing an in-house tracking system to work through the eSTAR process, rather than relying solely on the template: \"I recommend creating or modifying a tracking system using Excel or your existing tool. It\\'s best to discuss your plan with program management.\"'}),/*#__PURE__*/e(\"h3\",{children:\"The Future of eSTAR\"}),/*#__PURE__*/e(\"p\",{children:\"Near the end of her talk, Dr. Roy made it clear that eSTAR is here to stay, and that manufacturers will need to become adept at navigating the process eventually if they want to remain in business. Her final line was quite clear: \u201CThere is no other alternative.\u201D\"}),/*#__PURE__*/e(\"p\",{children:\"She also invited attendees to come see her at Essenvia\u2019s booth for one-on-one discussion, and recommended Essenvia\u2019s very thorough booklet on the essentials of the eSTAR process.\"}),/*#__PURE__*/e(\"h3\",{children:\"Mastering eSTAR with Essenvia\"}),/*#__PURE__*/e(\"p\",{children:\"Essenvia has developed a next-generation platform for Medtech submissions like eSTAR, allowing manufacturers to streamline the submission process and get to market more quickly. Essenvia has an extensive library of expert-approved submission templates, intuitive autofill features that draw on integrated regulator databases, centralized workflow management that makes it easy for teams to divide the labor, and real-time regulatory intelligence to help you keep track of competitor products.\"}),/*#__PURE__*/e(\"p\",{children:'Dr. Roy emphasized the platform\u2019s strong experience with eSTAR submissions: \"We have completed more than 350 submissions processed through the Essenvia platform, including eSTAR.\"'}),/*#__PURE__*/t(\"p\",{children:[\"To learn more about Essenvia \",/*#__PURE__*/e(i,{href:{webPageId:\"OhudbEura\"},openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"book a quick demo\"})}),\".\"]})]});export const richText9=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:\"Medical devices in the US (and the rest of the world) use a risk-based classification system that determines the rules and regulations and level of evidence necessary to obtain FDA permission to market a new or modified medical technology.\"}),/*#__PURE__*/e(\"p\",{children:\"In the US, the precise terminology of FDA cleared vs. approved arises from the statutory distinction between a sponsor marketing a Class II 510(k) vs. Class III PMA medical device. FDA marketing terminology for products that are Class I 510(k) Exempt is the same as with Class II 510(k)s \u2014 that is \u201CFDA Cleared\u201D.\"}),/*#__PURE__*/e(\"p\",{children:\"For De Novo 510(k)s, it\u2019s not clear what terminology sponsors should use. A quick search of recent listings in FDA\u2019s De Novo 510(k) database indicates that some sponsors on their websites describe a newly marketed De Novo 510(k) technology as \u201CFDA approved\u201D while others use the more conservative terminology of \u201CFDA cleared\u201D.\"}),/*#__PURE__*/e(\"p\",{children:\"Interestingly, the real-world implications of using incorrect terminology \u2014 for example inappropriately claiming that a Class II 510(k) device is \u201CFDA approved\u201D \u2014 while not advisable rarely results in a publicly disclosed FDA compliance enforcement action such as a Warning Letter.\"}),/*#__PURE__*/e(\"h2\",{children:/*#__PURE__*/e(\"strong\",{children:\"1976 Medical Device Amendments to FD&C Act\\xa0\\xa0\\xa0\\xa0\\xa0\"})}),/*#__PURE__*/e(\"p\",{children:\"The precise terminology of FDA-cleared vs. approved dates back to the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act (FD&C Act) which for the first time established a statutory framework designed specifically for FDA regulation of medical devices as opposed to FDA oversite of pharmaceuticals, dietary supplements, veterinary products, etc.\"}),/*#__PURE__*/t(\"h2\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Pathway to Market\"}),\" for Medical Devices \u2013 510(k) and PMA\"]}),/*#__PURE__*/e(\"p\",{children:\"The statutory framework of the Medical Device Amendments established 2 Pathways to Market for new or modified medical technologies:\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Statutory ProvisionCommon NameRisk ClassificationRegulatory Paradigm\"}),\"Premarket Notification510(k)Class II \u2014 ModerateSubstantial Equivalent (SE) to Predicate DevicePremarket ApprovalPMAClass III \u2014 HighReasonable Assurance of\",/*#__PURE__*/e(\"br\",{}),\"Safety and Effectiveness\"]}),/*#__PURE__*/e(\"h3\",{children:/*#__PURE__*/e(\"strong\",{children:\"1. FDA Premarket Notification \u2013 510(k) Submission\"})}),/*#__PURE__*/e(\"p\",{children:\"The Premarket Notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain US marketing clearance.\"}),/*#__PURE__*/e(\"p\",{children:\"Under section 510(k) of the FD&C Act, a manufacturer must submit a 510(k) to FDA at least 90 days before introducing or delivering for introduction, a device into interstate commerce for commercial distribution so the Agency can determine whether or not the device meets the criteria for market clearance.\"}),/*#__PURE__*/e(\"p\",{children:\"If FDA finds the device to be substantially equivalent, the sponsor receives an order, in the form of a letter, from FDA which states that the device can be legally marketed. This order \u201Cclears\u201D the device for commercial distribution in the US.\"}),/*#__PURE__*/e(\"h3\",{children:/*#__PURE__*/e(\"strong\",{children:\"2. FDA Premarket Approval \u2013 PMA Submission\"})}),/*#__PURE__*/e(\"p\",{children:\"The Premarket Approval or PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.\"}),/*#__PURE__*/e(\"p\",{children:\"PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device.\"}),/*#__PURE__*/e(\"p\",{children:\"PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).\"}),/*#__PURE__*/e(\"h2\",{children:/*#__PURE__*/e(\"strong\",{children:\"Marketing via FDA Clearance vs. FDA Approval\"})}),/*#__PURE__*/e(\"p\",{children:\"The 1976 Medical Device Amendments established different terminology for marketing 510(k) vs. PMA technologies as specified below. Using different languages suggests that there is a purposeful distinction between whether a new medical device comes to market via the 510(k) vs. PMA Regulatory Pathway.\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Marketing ApplicationSafety and Effectiveness Testing Requirements for Marketing\"}),\"FDA 510(k)To obtain \",/*#__PURE__*/e(\"strong\",{children:\"FDA Clearance\"}),\", the manufacturer must compare the new device to a similar legally marketed predicate device and demonstrate substantial equivalence.FDA PMA (Pre-Market Approval)To obtain \",/*#__PURE__*/e(\"strong\",{children:\"FDA Approval\"}),\", the manufacturer must provide sufficient testing results from the new device that demonstrate a reasonable assurance of safety and effectiveness.\"]}),/*#__PURE__*/e(\"p\",{children:\"In fact, there is no legal or commercial difference between whether a medical technology comes to market through FDA Clearance or FDA Approval.\"}),/*#__PURE__*/e(\"p\",{children:\"In both cases, what\u2019s important is that FDA acknowledges in writing (SE Letter vs. PMA Approval Order) that the manufacturer can introduce a new or modified medical device into commercial distribution.\"}),/*#__PURE__*/e(\"h3\",{children:/*#__PURE__*/e(\"strong\",{children:\"De Novo 510(k)s\"})}),/*#__PURE__*/t(\"h4\",{children:[/*#__PURE__*/e(\"strong\",{children:\"1.\"}),\" \",/*#__PURE__*/e(\"strong\",{children:\"Language from Sponsor Websites\"})]}),/*#__PURE__*/e(\"p\",{children:\"For De Novo 510(k)s, it\u2019s not clear what terminology the sponsor should use. A quick search of recent listings in FDA\u2019s De Novo 510(k) database indicates that some sponsors on their websites describe a newly marketed De Novo 510(k) technology as \u201CFDA approved\u201D while others use the more conservative terminology of \u201CFDA cleared\u201D. The following are examples of newly marketed De Novo 510(k) devices.\\xa0 One company website specifies FDA approved and the other FDA cleared.\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(i,{href:\"https://www.neurolutions.com/ipsihand\",openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"Neurolutions IpsiHand\"})}),/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{}),\"Upper Extremity Rehabilitation\",/*#__PURE__*/e(\"br\",{}),\"System\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{}),\"DEN200046 04/23/2021\"]}),/*#__PURE__*/e(\"img\",{alt:\"\",className:\"framer-image\",\"data-framer-asset\":\"data:framer/asset-reference,kl8bXuaPfTas0BGRpDy1Rf2hJmI.png\",\"data-framer-height\":\"792\",\"data-framer-width\":\"1662\",height:\"396\",src:\"https://framerusercontent.com/images/kl8bXuaPfTas0BGRpDy1Rf2hJmI.png\",style:{aspectRatio:\"1662 / 792\"},width:\"831\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(i,{href:\"https://nightware.com/?ref=essenvia.com\",openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"NightWare\"})}),/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{}),\"Apple Watch App for PTSD\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{}),\"DEN200033 11/06/2020\"]}),/*#__PURE__*/e(\"img\",{alt:\"\",className:\"framer-image\",\"data-framer-asset\":\"data:framer/asset-reference,xS0pYFeNbRcC761DAZVetcQELBA.png\",\"data-framer-height\":\"468\",\"data-framer-width\":\"812\",height:\"234\",src:\"https://framerusercontent.com/images/xS0pYFeNbRcC761DAZVetcQELBA.png\",style:{aspectRatio:\"812 / 468\"},width:\"406\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]}),/*#__PURE__*/e(\"img\",{alt:\"\",className:\"framer-image\",\"data-framer-asset\":\"data:framer/asset-reference,5ou7JntV5SRiUTj1ZzGwte0aAkY.png\",\"data-framer-height\":\"290\",\"data-framer-width\":\"1528\",height:\"145\",src:\"https://framerusercontent.com/images/5ou7JntV5SRiUTj1ZzGwte0aAkY.png\",style:{aspectRatio:\"1528 / 290\"},width:\"764\"}),/*#__PURE__*/e(\"h4\",{children:/*#__PURE__*/e(\"strong\",{children:\"2. Regulatory Paradigm for De Novo 510(k)s is Most Similar to PMA, Not Traditional 510(k)\"})}),/*#__PURE__*/e(\"p\",{children:\"Unlike traditional 510(k)s and PMAs, the De Novo Letter that sponsors receive from FDA allowing them to market a new device does not include terminology such as \u201CFDA cleared\u201D or \u201CFDA approved\u201D.\"}),/*#__PURE__*/e(\"p\",{children:\"Instead, the De Novo Letter provides the following boilerplate language:\"}),/*#__PURE__*/t(\"p\",{children:[\"\u201CAfter review of the information submitted in the De Novo request, FDA has determined that \u2026 [your device] can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls \",/*#__PURE__*/e(\"strong\",{children:\"provide reasonable assurance of the safety and effectiveness\"}),\" of the device type.\u201D\"]}),/*#__PURE__*/e(\"p\",{children:\"According to the above, the regulatory paradigm for the De Novo 510(k) pathway to market is very similar to the PMA \u2013 that is for the sponsor to demonstrate a reasonable assurance of safety and effectiveness.\"}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"strong\",{children:\"3. So What Terminology Should a Sponsor Use?\"})}),/*#__PURE__*/e(\"p\",{children:\"Since a PMA sponsor appropriately refers to their marketed device as \u201CFDA approved\u201D, the above Regulatory Analysis provides the sponsor of a De Novo 510(k) ample justification to use the same language for marketing their medical device.\"}),/*#__PURE__*/e(\"p\",{children:\"So De Novo 510(k) sponsors can confidently use \u201CFDA approved\u201D as appropriate terminology for product Websites, Advertising, and Promotional Materials, Sell Sheets, etc.\"}),/*#__PURE__*/e(\"h2\",{children:/*#__PURE__*/e(\"strong\",{children:\"Real World Implications of Using Incorrect Terminology\"})}),/*#__PURE__*/e(\"p\",{children:\"The real-world implications of using incorrect terminology (FDA cleared vs. FDA approved) are surprisingly low risk \u2014 even considering regulatory and/or legal liability.\"}),/*#__PURE__*/e(\"h3\",{children:/*#__PURE__*/e(\"strong\",{children:\"1. Misbranded\"})}),/*#__PURE__*/e(\"p\",{children:\"FDA clearly has the authority to determine if a medical device is \u201Cmisbranded\u201D.\\xa0 This is most commonly the result of some aspect(s) of product labeling which is found by the FDA to be false or misleading.\"}),/*#__PURE__*/t(\"h3\",{children:[/*#__PURE__*/e(\"strong\",{children:\"2\"}),\". \",/*#__PURE__*/e(\"strong\",{children:\"Labeling for 510(k) Device Incorrectly Specifies \u201CFDA Approved\u201D\"})]}),/*#__PURE__*/e(\"p\",{children:\"What are the consequences if a sponsor (either inadvertently or perhaps intentionally) incorrectly claims that a Class II 510(k) device is \u201CFDA approved\u201D?\"}),/*#__PURE__*/e(\"p\",{children:\"According to the letter of the law, this would qualify as misbranding.\\xa0 But the real-world consequences are actually insignificant.\"}),/*#__PURE__*/e(\"p\",{children:\"FDA\u2019s Compliance and Quality Staff is a relatively small group with limited resources.\\xa0 When a product is found to be misbranded, FDA typically pursues enforcement action only if the violation meets either of the following:\"}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Misbranding could reasonably result in patient harm\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Misbranding characterizes device therapy as more effective than was demonstrated in 510(k) submission\"})})]}),/*#__PURE__*/t(\"h3\",{children:[/*#__PURE__*/e(\"strong\",{children:\"3\"}),\". \",/*#__PURE__*/e(\"strong\",{children:\"Warning Letter From FDA \u2013 Compliance Enforcement Action\"})]}),/*#__PURE__*/e(\"p\",{children:\"FDA typically reserves the use of a Warning Letter for compliance violations that meet one of the following \u2013 in order from most common to least:\"}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Noncompliance with Quality Systems Regulation (QSR)\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Class II Device has been marketed without 510(k) filing\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Failure to properly conduct Postmarket Surveillance\"})})]}),/*#__PURE__*/e(\"p\",{children:\"In FDA\u2019s Warning Letter database, there are no instances of misbranding from using incorrect marketing status terminology.\"}),/*#__PURE__*/e(\"p\",{children:\"So while not advisable, simply misbranding a Class II 510(k) device by using the incorrect terminology of FDA approved (as opposed to FDA cleared) would rarely if ever result in a compliance enforcement action such as FDA issuing a Warning Letter.\"}),/*#__PURE__*/e(\"h3\",{children:/*#__PURE__*/e(\"strong\",{children:\"About Essenvia\"})}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(i,{href:{webPageId:\"pkCFtrOGK\"},openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"Essenvia\"})}),\"\\xa0is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.\"]}),/*#__PURE__*/t(\"p\",{children:[\"Essenvia\\xa0is designed to help drastically reduce submission errors, streamline data and information gathering, save time, improve collaboration and help you submit a close to rejection proof as a possible submission for 510k, PMA, IDE, Technical File for CE Mark, etc.Schedule a \",/*#__PURE__*/e(i,{href:{webPageId:\"OhudbEura\"},openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"demo\"})}),\" now to find out how Essenvia can help you with your regulatory submissions.\"]})]});export const richText10=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:\"One of the hardest parts of developing a new device is determining exactly how to proceed with regulatory pathway, especially in the case of devices where initial assessments indicate multiple potential classes or uncertainty around clearly-defined class. The FDA can help manufacturers through this process. Section 513(g) of the Federal Food, Drug, and Cosmetic Act outlines a procedure for device manufacturers to work with the FDA to determine how their prospective device would be classified. This is an essential first step in determining a device\u2019s development and approval process.\"}),/*#__PURE__*/e(\"h2\",{children:\"Section 513(g)\"}),/*#__PURE__*/e(\"p\",{children:\"Section 513(g) of the Federal Food, Drug, and Cosmetics act allows device manufacturers to submit a written request to the secretary of the FDA regarding how a device would be classified, and to receive a written reply including how the device would be classified, which regulations would apply to it, and what the approval process for it would look like, within 60 days. This is somewhat more complex than writing a personal letter to the secretary of the FDA, though. The 513(g) process is much more formalized and codified than the letter of the law indicates.\"}),/*#__PURE__*/e(\"p\",{children:\"The key reason for submitting a 513(g) request is for manufacturers to learn which regulations will apply to their device and especially whether it will be subject to 510(k) regulations. The majority of medical devices are covered by 510(k), which provides a clear regulatory pathway for a device to be developed, tested, documented, manufactured, and serviced. Some devices will not be subject to 510(k), especially in cases where manufacturers are simply making a small change to an already-approved device. This can save manufacturers weeks or months of regulatory back-and-forth and documentation submissions, and even in cases where a 510(k) is required, manufacturers can learn about  the least-cumbersome way of getting their devices approved.\"}),/*#__PURE__*/e(\"h2\",{children:\"How to Submit a 513(g) Application\"}),/*#__PURE__*/t(\"p\",{children:[\"A 513(g) application can be submitted online. For devices regulated by CDRH, directions for submitting online can be found \",/*#__PURE__*/e(i,{href:\"https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-medical-device-submissions\",openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"here\"})}),\", while manufacturers of devices regulated by CBER should go \",/*#__PURE__*/e(i,{href:\"https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper-format-cber-regulated-products\",openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"here\"})}),\". Applications should include a cover letter, a description of the device, a description of the indicated use of the device, as well as proposed labeling and marketing materials for the device.\"]}),/*#__PURE__*/e(\"p\",{children:\"The cover letter should clearly state that the document is a 513(g) request and include the date of the request, the name of the device, and the requester\u2019s name, contact information, and signature. Cover letters are also essential parts of the process because they provide an opportunity for manufacturers to ask questions or even lay out arguments about potential regulatory categories for a proposed device. This can not only streamline the reply process, but also predispose the FDA to view a device in a favorable way for the manufacturer.\"}),/*#__PURE__*/t(\"p\",{children:[\"Submitting a 513(g) application will also require the \",/*#__PURE__*/e(i,{href:\"https://www.fda.gov/media/78463/download\",openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"payment of user fees\"})}),\". The FDA is legally required to collect these fees for any requests for information, and they won\u2019t process a request until all fees are paid. This can include facility registration fees, so it\u2019s a good idea to review your company\u2019s accounts to make sure these fees are up to date before proceeding. Notably, these fees can be refunded if the submitted request does not qualify as a 513(g) request.\"]}),/*#__PURE__*/e(\"h2\",{children:\"FDA Feedback: What They Will and Won\u2019t Provide\"}),/*#__PURE__*/e(\"p\",{children:\"The FDA will tell a 513(g) applicant:\"}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Whether or not the described product qualifies as a medical device. If the product does not qualify as a medical device, it may fall under other forms of regulation, but this is generally an ideal outcome for manufacturers since medical devices are heavily regulated and have complex approval processes.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"The type and class of medical device the product will be regulated as, and any application requirements that are specific to this class.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Whether premarket approval application (PMA) or a 510(k) application are required. Some devices require one of these, some both, and some neither.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Special guidance and requirements for the particular device class. Some devices have more stringent sanitation, handling, or warning label requirements, especially those that include radioactive components or potentially-lethal drug doses.\"})})]}),/*#__PURE__*/e(\"p\",{children:\"The FDA will not tell a 513(g) applicant:\"}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Whether a device is substantially equivalent. This means manufacturers will need to do their own research into other products on the market in order to determine if theirs is unique.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Whether the device is safe or effective. This can only be determined after a long and rigorous testing process, and the FDA will not speculate here. They will need to see the results of multiple studies in compliance with other FDA regulations.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Final determinations regarding the class of the device. The development and regulatory process may reveal new functions for a device or prove proposed functions infeasible, meaning that a device\u2019s class may change between a 513(g) request and final approval.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"Whether a manufacturer is authorized to market a device. This is another step that will have to wait until later in the regulatory process.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/e(\"p\",{children:\"What studies may be necessary for approval and marketing of a product.\"})})]}),/*#__PURE__*/e(\"h2\",{children:\"Conclusion\"}),/*#__PURE__*/e(\"p\",{children:\"The 513(g) application process is an important tool for manufacturers looking to determine the best course of action for the development of devices. Knowing exactly what a 513(g) application will and won\u2019t tell a medical device developer is necessary for taking further regulatory steps, and getting clear guidance from the FDA can help developers avoid risky over investment in devices that aren\u2019t likely to meet FDA approval. Especially in today's constantly-shifting regulatory environment with novel devices forcing the FDA to rethink existing regulations, staying informed about regulatory procedures and next steps is a big competitive advantage. \"}),/*#__PURE__*/e(\"h2\",{children:\"About Essenvia\"}),/*#__PURE__*/t(\"p\",{children:[\"Essenvia is a regulatory lifecycle management tool designed to help you optimize the entire regulatory operations process. Our solutions include an innovative approach to building your regulatory submissions like \",/*#__PURE__*/e(i,{href:{webPageId:\"u5Ge47Nh2\"},openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"510(k)\"})}),\"\\xa0and \",/*#__PURE__*/e(i,{href:{webPageId:\"g5zTyvE5e\"},openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"MDR\"})}),\" as well as post-market submissions like Regulatory Change Assessment and Post Market Surveillance. Essenvia is designed to reduce errors, streamline processes, and guarantee faster regulatory clearance for your medical device.\"]}),/*#__PURE__*/t(\"p\",{children:[\"Schedule a \",/*#__PURE__*/e(i,{href:{webPageId:\"OhudbEura\"},openInNewTab:!0,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"demo\"})}),\" now to find out how Essenvia can help you with your regulatory submissions.\"]})]});export const richText11=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"h2\",{children:\"The History of eSTAR\"}),/*#__PURE__*/t(\"p\",{children:[\"The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 included provisions requiring the FDA to improve the electronic submission process for 510(k) filings. The FDA started working on this new process in September of 2018, and the Center for Biologics Evaluation and Research (CBER) piloted an initial program called the Electronic Submission Template and Resource Pilot Program, which eventually evolved into eSTAR. The core of eSTAR is a PDF template designed to guide users through the 510(k) submission process. The goal here is efficiency, both for the FDA and for submitting organizations.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]}),/*#__PURE__*/e(\"h2\",{children:\"What eSTAR Requires\"}),/*#__PURE__*/t(\"p\",{children:[\"Until October 1, 2023, eSTAR will remain a voluntary process that is free to use for medical device applicants wishing to submit either a 510(k) or a De Novo to the CDRH, though it can\u2019t be used for many other types of submission types yet. One key note is that standard submission fees for De Novo and 510(k) do still apply.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]}),/*#__PURE__*/t(\"p\",{children:[\"One thing that is not required for eSTAR submissions is Refuse to Accept (RTA) reviews. These preliminary reviews of submissions aren\u2019t necessary for eSTAR submissions because the eSTAR template in some way works of this review checklist and is meant to aid submitting manufacturers know if their submission is complete. Incomplete eSTAR submissions simply won\u2019t be reviewed.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]}),/*#__PURE__*/e(\"h2\",{children:\"Submission Guidelines\"}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(i,{href:\"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab\",openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"\u201CProviding Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act\u201D\"})}),\" contains essential guidance regarding the development of templates for electronic submissions, which led to the creation of eSTAR templates and could be used for creating proprietary templates. \",/*#__PURE__*/e(i,{href:\"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-510k-submissions?utm_medium=email&utm_source=govdelivery\",openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"\u201CElectronic Submission Template for Medical Device 510(k) Submissions\u201D\"})}),\" contains final FDA guidelines for electronic submissions, including exemptions for situations where users may not need to use eSTAR. Consulting these documents is an essential first step in determining whether and how users need to submit via eSTAR.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]}),/*#__PURE__*/t(\"p\",{children:[\"Users can currently send in eSTAR submissions via two methods: Online via the Customer Collaboration Portal, or by mailing a digital copy of the eSTAR PDF on a USB drive, CD, or DVD. For mail-in submissions, users should download the eSTAR PDF template for either an In Vitro or non-In Vitro device and fill it out according to the directions. Once the template is complete, users can save a copy to send in by mail instead of submitting online. It is not necessary for eSTAR submission to comply with \",/*#__PURE__*/e(i,{href:\"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions\",openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"the FDA\u2019s eCopy Guidance\"})}),\" document, but any additional files beyond the eSTAR PDF itself will need to comply with these guidelines. Users also don\u2019t need to include an Indications for Use page, a Premarket Review Submission Cover Sheet, or a Declaration of Conformity, since these documents are built into the eSTAR PDF. It is usually a good idea to merge all files into a single PDF document for mail-in submissions.\"]}),/*#__PURE__*/e(\"p\",{children:\"Note: Users who are submitting a 510(k) product change will need to include a justification for not including original information in sections that did not change, since the eSTAR template will still automatically require this information.\"}),/*#__PURE__*/e(\"h2\",{children:\"Using the eSTAR Template\"}),/*#__PURE__*/e(\"img\",{alt:\"\",className:\"framer-image\",\"data-framer-asset\":\"data:framer/asset-reference,ev1tXXBGiflrJnsVKSrXcSmiD8.png\",\"data-framer-height\":\"854\",\"data-framer-width\":\"667\",height:\"427\",src:\"https://framerusercontent.com/images/ev1tXXBGiflrJnsVKSrXcSmiD8.png\",style:{aspectRatio:\"667 / 854\"},width:\"333\"}),/*#__PURE__*/t(\"p\",{children:[\"The above image is from the Device Description section. It is designed to prompt users for all required information by turning sections red if they need to be filled out, turning them green when they have been filled out, and turning them gray if they are optional. These forms also use cascading drop-down menus, meaning that as you answer some questions, others may automatically appear based on your responses. One key note here: Most submissions will require the inclusion of attachments. It\u2019s a good idea to break these attachments up into small individual sections, since the form will not be able to re-use submitted files in different sections.\",/*#__PURE__*/e(\"br\",{}),/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})]}),/*#__PURE__*/e(\"h2\",{children:\"Tracking your Submission\"}),/*#__PURE__*/t(\"p\",{children:[\"The FDA\u2019s \",/*#__PURE__*/e(i,{href:\"https://fda-cdrh.okta.com/login/login.htm?fromURI=%2Fapp%2Ffda-cdrh_customercollaborationportal_1%2Fexk5t7i49upPRHASh4h6%2Fsso%2Fsaml\",openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"Customer Collaboration Portal (CCP)\"})}),\" will allow your Official Correspondent to track your submission\u2019s progress. It will be necessary to create an account for this portal for first-time users.\"]}),/*#__PURE__*/e(\"h2\",{children:\"Potential Challenges\"}),/*#__PURE__*/e(\"p\",{children:\"Despite the improvements that eSTAR brings to the 510(k) submission process, there are organizational and assembly challenges associated with overall submission process that needs to be addressed. It is still early to look at FDA data that indicates 71% of submissions have led to additional information requests, 34% resulted in a refusal to accept, and 7% ended up on technical hold. This leads to a number of problems for businesses:\"}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Submission delays\"}),\". Especially with current regulations and procedures being in flux, businesses are constantly working to catch up and make changes to existing submissions.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"High training costs\"}),\". Managing the eSTAR system, other FDA regulations, and the submission tracking process all require a good deal of hands-on learning before employees can handle them without errors.\"]})}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"High overhead\"}),\". Manufacturers will still need to manage their unique templates, handle countless attachments, and communicate with multiple stakeholders in order to comply with eSTAR regulations.\"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]})]}),/*#__PURE__*/e(\"h2\",{children:\"What Causes These Challenges?\"}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(34, 34, 34)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"The eSTAR form is quite cumbersome\"}),\". While one would expect that the field-dependent structure of the form would make submissions much more straightforward in theory, this isn\u2019t always the case in practice. Some fields fail to properly generate or populate on some devices or Acrobat readers. The PDF will also automatically blank out fields that are filled out of order or with incorrect information. The PDF is also not very effective at checking the quality of the information entered in each field. A red box is a clear sign that a field hasn\u2019t been filled out, but it\u2019s possible to enter incorrect information and get a green box from the PDF\u2013leading to requests for more information and another round of back-and-forth.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(34, 34, 34)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"The Acrobat eSTAR form is an offline document that doesn\u2019t allow for collaboration.\"}),\" This means that teams have to either have a single person entering information on the eSTAR PDF, or carefully save and hand off the Acrobat form from one department to department. This leads to issues with embedding files, duplicating content efforts, and losing master copies and historical context. With up to seven different teams working on the average eSTAR submission, manufacturers often need to create an in-house template to collect and organize information before inputting it into the PDF.\"]})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(34, 34, 34)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Rapidly changing Medical device regulations are taking their toll on eSTAR maintenance burden for Regulatory affairs teams\"}),\". Since 2018 when this initiative began, there have been several changes to the eSTAR framework roughly once every 2 months. This means that regulatory affairs teams are constantly forced to review their submissions and make changes to accommodate new regulations, as well as duplicating all the effort they put into internal documents and templates.\"]})}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(34, 34, 34)\",\"--framer-text-decoration\":\"none\"},children:[/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Attachments are confusing with eSTAR\"}),\". Engineering drawings need to be compiled in a separate document, while other content needs to be included in the main document, and these requirements tend to change about as frequently as others adding the training burden for regulatory affairs teams.\"]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]})]}),/*#__PURE__*/e(\"h2\",{children:\"Best Practices\"}),/*#__PURE__*/e(\"p\",{children:\"So, with all of these issues, how can regulatory affairs teams keep up with eSTAR requirements?\"}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(34, 34, 34)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/e(\"p\",{children:\"Templates. One first step should be to create your own copies of the eSTAR templates for internal use. This will make it much easier to input the required information collaboratively.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(34, 34, 34)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/e(\"p\",{children:\"File storage. Secure, cloud-based storage is essential for managing eSTAR submissions. The number, size, diversity, and potential sensitivity of these files mean that keeping them all in one place with controlled access is essential.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(34, 34, 34)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/e(\"p\",{children:\"Planning. Create clear checklists with timelines to assign specific parts of the eSTAR process to the relevant departments, make sure the work gets done, and keep track of deadlines. The eSTAR process generally takes several days to complete as well as to be approved, so it\u2019s essential to build in extra time.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"11px\",\"--framer-text-color\":\"rgb(34, 34, 34)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/e(\"p\",{children:\"Training and Standard Operating Procedures. Companies should plan on at least 2 weeks of training time for each regulatory change in eSTAR\u2019s framework and requirements. Since these changes happen regularly, it\u2019s wise to invest heavily in in-house training staff to handle this workload, and in-house documentation teams to create and update SOP documents.\"})})]}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})}),/*#__PURE__*/e(\"h2\",{children:\"About Essenvia\"}),/*#__PURE__*/e(\"p\",{children:\"Essenvia is the only regulatory platform ready to streamline eSTAR submissions and walk you through each step in the eSTAR process. Regulatory Affairs teams are already using Essenvia to:\"}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"10.5px\",\"--framer-text-color\":\"rgb(68, 71, 70)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/e(\"p\",{children:\"Save time and quickly adapt to eSTAR (including the new versions released by the FDA)\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"10.5px\",\"--framer-text-color\":\"rgb(68, 71, 70)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/e(\"p\",{children:\"Reduce stress by co-authoring eSTAR submissions directly inside of the submission file, leading to fewer version mismatch and file fragmentation headaches\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"10.5px\",\"--framer-text-color\":\"rgb(68, 71, 70)\",\"--framer-text-decoration\":\"none\"},children:/*#__PURE__*/e(\"p\",{children:\"Ensure a 100% acceptance rate by the FDA\"})})]}),/*#__PURE__*/t(\"p\",{children:[\"Watch this \",/*#__PURE__*/e(i,{href:\"https://essenvia-1.wistia.com/medias/rf46pu7kqv\",openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\"3-minute video\"})}),\" to understand how Essenvia can help you adapt faster to eSTAR or Schedule a\",/*#__PURE__*/e(i,{href:{webPageId:\"OhudbEura\"},openInNewTab:!1,smoothScroll:!1,children:/*#__PURE__*/e(\"a\",{children:\" demo\"})}),\" now to find out how Essenvia can help you with your regulatory submissions.\"]})]});export const richText12=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"strong\",{children:\"Periodic Safety Update Report (PSUR) MDCG guidelines: What advantages do IVD manufacturers get?\"})}),/*#__PURE__*/e(\"p\",{children:\"The Medical Device Coordination Group (MDCG) released a new guidance paper last year (MDCG-2022-21). This paper covers Periodic Safety Update Report (PSUR) in accordance with EU Regulation 2017/745 (MDR). The PSUR serves as a guideline for both medical devices and in-vitro diagnostic medical devices (IVDs) in Europe. This regulation ((EU) 2017/746 (IVDR)) states that manufacturers of both class C and class D IVDs are required to create, maintain, and regularly update a PSUR. Article 81 and Annex III outline the necessary steps for this process. Notably, they state that the PSUR should include the results of a risk-benefit analysis, the main findings of the post-market performance follow-up (PMPF), the number of devices currently on the market, an estimate of the demographic information of device users, and ideally an estimate of how often the device is used.\"}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"strong\",{children:\"Not Required, but Still Useful\"})}),/*#__PURE__*/e(\"p\",{children:\"IVDs are not actually governed by MDCG-2022-21, but it can still serve as a helpful document for IVD manufacturers, since it will provide useful guidance on how to meet PSUR legal requirements. The MDCG also suggests that guidance for IVDR may be similar to the guidance for MDR, at least for overlapping or similar parts. Even manufacturers of class A and class B IVDs will find useful information in these guidelines even though PSURs are not required for these devices. PSUR guidelines include information about how to present information in a post-market surveillance (PMS) report, as is required by IVDR Article 80.\"}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"strong\",{children:\"How Legacy Devices are Affected\"})}),/*#__PURE__*/e(\"p\",{children:\"Legacy IVD medical devices have been governed by PMS and PMPF standards since May 26, 2022. Certain exceptions do apply for legacy devices, as outlined in MDCG-2022-8. This includes the absence of a requirement to update the Summary of Safety Perrformance (SSP) and Performance Evaluation report (PER), since these documents were not required by the IVDD. PMS results for all legacy devices can be reported in a PMS report, as outlined in Article 80, without the need to create a PSUR, as outlined in Article 81, thanks to different classification methods between IVDD and IVDR. Manufacturers of legacy devices still have the option of creating a PSUR for these devices if they so choose.\"}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"strong\",{children:\"What should the PSUR Include?\"})}),/*#__PURE__*/e(\"p\",{children:\"It is important to note that, as outlined in MDCG-2022\u201321 for IVDs, the PSUR should be its own separate document included as part of the technical file. It should provide a summary of all post-market surveillance activities and all data gathered, and also include an analysis based on that device\u2019s PMS plan. This doesn\u2019t mean that it\u2019s necessary to repeat all of the statistics and reports from the PMS Plan. A summary of the results and conclusions are all that\u2019s required, and manufacturers will need to include a clear explanation of any unnecessary facts in the report. While a general overview of statistics and results is all that\u2019s required for a PSUR, it should also include detailed information about any serious incidents regarding safety and corrective actions taken, as well as information about less-serious incidents and unwanted side effects. PSURs should also include information from relevant literature including databases, registers, specialist and technical reports, as well as trend reporting, information from users, distributors, and importers, and a clear record of complaints and feedback. PSUR reports must also include any publicly-available information about similar devices to provide a basis for comparison.\"}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})}),/*#__PURE__*/e(\"p\",{children:/*#__PURE__*/e(\"strong\",{children:\"Timetables for Legacy Devices\"})}),/*#__PURE__*/e(\"p\",{children:\"The organizational template for the PSUR is outlined in Annex I of MDCG-2022\u201321. Annex II includes tables which show how to present necessary information on sales volume, estimated size, and population characteristics of device users, as well as serious incidents and FSCA and CAPA as they relate to the device in question. Each device or group/category of devices needs its own PSUR, and manufacturers must identify a \u201Cleading device\u201D that dictates the schedule for that PSUR. Data collection should start on the date that the device is certified by the IVDR, and end on the date of the IVDR certificate\u2019s anniversary or an agreed-upon timetable as negotiated with the Notified Body. For the first PSUR, legacy devices should start their data collection time on May 26, 2022, and also treat that date as the IVDR Date of Application (DoA).\"})]});export const richText13=/*#__PURE__*/t(r.Fragment,{children:[/*#__PURE__*/e(\"p\",{children:\"You can document Risk in a 510(k) by comparing subject device with one or more similar legally marketed devices to support substantial equivalency claims. To legally market your medical device, you need to demonstrate it is as safe and effective as any other legally marketed product that is not subject to PMA (21 CFR 807.92(a)(3)).\"}),/*#__PURE__*/e(\"p\",{children:\"The blog describes key factors for documenting risk management in 510(k) submissions. Here is a list of questions we should understand:\"}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"What is a predicate device and how to claim substantial equivalence to a proposed device?\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Types of devices needing risk management for 510(k) submissions?\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Risk management requirements for a Traditional 510(k)?\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Where can one find 510(k) risk management requirements?\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"How can manufacturers demonstrate device safety?\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Key factors for documenting risks before submitting 510(k)?\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Contents of software related documentation?\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"What are the contents of risk related documentation?\"})})]}),/*#__PURE__*/e(\"h2\",{children:\"\\xa0\"}),/*#__PURE__*/e(\"h2\",{children:/*#__PURE__*/e(\"strong\",{children:\"Using Substantial equivalence to demonstrate risk management in the 510(k) submission.\\xa0\"})}),/*#__PURE__*/e(\"p\",{children:\"A predicate device is a legally marketed device subjected to premarket approval. We can demonstrate Substantial Equivalence by comparing the applicant\u2019s device to a cleared predicate device, if:\"}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"it was cleared through the 510(k) process\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"it was legally marketed prior to May 28, 1976 (pre-amendments device)\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"it was originally on the U.S. market as a Class III device (Premarket approval) and later down-classified to Class II or I\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"it is a 510(k)-exempt device\"})})]}),/*#__PURE__*/e(\"p\",{children:\"We can demonstrate substantial equivalence if predicate device has:\"}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:[/*#__PURE__*/e(\"p\",{children:\"The same intended use as the predicate; and\"}),/*#__PURE__*/e(\"ul\",{children:/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"the same technological characteristics as the predicate\"})})})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:[/*#__PURE__*/e(\"p\",{children:\"The same intended use as the predicate; and\"}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"different technological characteristics and the information submitted to FDA and\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"does not raise new questions of safety and effectiveness; and\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"demonstrates that the device is at least as safe and effective as the legally marketed device.\"})})]})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:[/*#__PURE__*/e(\"p\",{children:\"Same technical characteristics can be:\"}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"The design\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Energy used or delivered\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Materials of construction\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Performance\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Safety\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Effectiveness\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Labeling\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Biocompatibility\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Environmental conditions\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Storage/ transport\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"operating\"})})]})]})]}),/*#__PURE__*/e(\"p\",{children:\"If the new device has some different technological characteristics the differences must not raise questions of safety or effectiveness when you\u2019re testing the device as safe and effective as the predicate device. However, if testing is done in accordance with FDA recognized standard then certificate of compliance to that standard is sufficient for the submission, and global test information or test data is not required.\"}),/*#__PURE__*/e(\"p\",{children:\"A simple way to show substantial equivalence is to create a comparison table including:\\xa0\"}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:[/*#__PURE__*/e(\"p\",{children:\"Technological specifications mentioned below:\"}),/*#__PURE__*/t(\"ul\",{children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Intended use, Indications for use\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Target population, Anatomical sites, where used (hospital, home, etc.)\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Energy used and/or delivered\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Human factors, Design, Performance, Standards met, Materials, Biocompatibility, Compatibility with environment and other devices\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Sterility, Electrical safety, Mechanical safety, Chemical safety, Thermal safety, Radiation safety\"})})]})]}),/*#__PURE__*/t(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:[/*#__PURE__*/e(\"p\",{children:\"A Narrative discussing similarities and differences between new and predicate device\"}),/*#__PURE__*/e(\"h2\",{children:/*#__PURE__*/e(\"br\",{className:\"trailing-break\"})})]})]}),/*#__PURE__*/e(\"h2\",{children:/*#__PURE__*/e(\"strong\",{children:\"Devices requiring risk management for 510(k) submission.\"})}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Risk management requirements are only for devices that contain software.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Abbreviated 510(k)s generally require declarations of conformity and risk management documents\"})})]}),/*#__PURE__*/e(\"h2\",{children:/*#__PURE__*/e(\"strong\",{children:\"Risk management requirements for a Traditional 510(k).\\xa0\"})}),/*#__PURE__*/t(\"p\",{children:[\"Only embedded software, driven by or standalone software and devices with software component must include \",/*#__PURE__*/e(\"strong\",{children:\"Hazard Identification\"}),\" and \",/*#__PURE__*/e(\"strong\",{children:\"Risk Assessment\"}),\" in 510(k)s.\"]}),/*#__PURE__*/e(\"p\",{children:\"When there is insufficient information to create general controls, special controls provide reasonable assurance of safety and effectiveness. It assures FDA that hazards related to device development process were subject to controls and mitigations.\"}),/*#__PURE__*/t(\"p\",{children:[\"You should include \",/*#__PURE__*/e(\"strong\",{children:\"Risk Control Verification and Validation \"}),\"requirements under\"]}),/*#__PURE__*/e(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/t(\"p\",{children:[\"Packaging Validation\",/*#__PURE__*/e(\"br\",{}),\"\u2022 Sterilization Validation\",/*#__PURE__*/e(\"br\",{}),\"\u2022 Biocompatibility\",/*#__PURE__*/e(\"br\",{}),\"\u2022 Software Verification Validation\",/*#__PURE__*/e(\"br\",{}),\"\u2022 Electrical Safety and EMC\",/*#__PURE__*/e(\"br\",{}),\"\u2022 Bench/Pre-Clinical Performance Testing\",/*#__PURE__*/e(\"br\",{}),\"\u2022 Animal Performance Testing\",/*#__PURE__*/e(\"br\",{}),\"\u2022 Clinical Performance Testing\"]})})}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Risks to Users and Patients \"}),\"are addressed in the Instructions for Use (IFU) as warnings, contraindications, and precautions (typically because of usability studies and hazard analysis).\"]}),/*#__PURE__*/t(\"p\",{children:[/*#__PURE__*/e(\"strong\",{children:\"Risk-Benefit Analysis\"}),\" is required in Special 510(k)s, De Novo applications, Humanitarian Device Exemptions, and PMAs. It is not required for traditional 510(k).\"]}),/*#__PURE__*/e(\"h3\",{children:/*#__PURE__*/e(\"strong\",{children:\"Where can one find 510(k) risk management requirements?\"})}),/*#__PURE__*/e(\"p\",{children:\"Design validation-software validation and risk analysis (21 CFR 820.30) FDA and EU CE Marking compliance- recognize ISO 14971 standard:\"}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"FDA recognizes ISO 14971:2019\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"EU recognizes EN ISO 14971:2019 (differences include omission of Annexes, decoupling of standards to MDR regs),\"})})]}),/*#__PURE__*/e(\"h3\",{children:/*#__PURE__*/e(\"strong\",{children:\"Best practices to address risks in 510(k) submissions\"})}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Look for appropriate Special Controls Guidance Docs in the FDA Guidance Document\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Use Guidance Documents for Controls and Risk Management Requirements\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Examine the guidance and determine which standards, testing, and hazard/risk analyses are appropriate.\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Ensure extensive testing\"})})]}),/*#__PURE__*/e(\"h2\",{children:/*#__PURE__*/e(\"strong\",{children:\"How to demonstrate device safety?\"})}),/*#__PURE__*/e(\"p\",{children:\"The GHTF/SG1-N11:2008 in 10.0 Risk Analysis and Control Summary states that \u201CThe STED [Summary Technical Documentation] should contain a summary of the risks identified during the risk analysis process and how these risks have been controlled to an acceptable level. Preferably, this risk analysis should be based on recognized standards and be part of the manufacturer\u2019s risk management plan.\u201D\"}),/*#__PURE__*/e(\"h2\",{children:/*#__PURE__*/e(\"strong\",{children:\"Factors to consider regarding risks before submitting 510(k)?\"})}),/*#__PURE__*/e(\"h3\",{children:/*#__PURE__*/e(\"strong\",{children:\"Human factors:\"})}),/*#__PURE__*/e(\"p\",{children:\"\u201CMedical device manufacturers are required to follow FDA\u2019s Human Factors guidance and regulations to help ensure safe use of these devices.\u201D \u2013 CDRH website\"}),/*#__PURE__*/e(\"p\",{children:\"Recognized standards include ISO 14971 risk management standard, IEC 62366 (joint ISO/IEC standard applying to all devices), IEC 60601-1-6 and AAMI HE75. To comply with standards,\"}),/*#__PURE__*/t(\"ul\",{style:{\"--framer-font-size\":\"16px\",\"--framer-text-alignment\":\"left\",\"--framer-text-color\":\"rgb(33, 37, 41)\",\"--framer-text-transform\":\"none\"},children:[/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Manufacturers will have to develop usability specifications for devices\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 0)\"},children:/*#__PURE__*/e(\"p\",{children:\"Manufacturers should explore usability issues as part of the risk management process in compliance with standards\"})}),/*#__PURE__*/e(\"li\",{\"data-preset-tag\":\"p\",style:{\"--framer-font-size\":\"18px\",\"--framer-line-height\":\"1.5em\",\"--framer-text-color\":\"rgb(0, 0, 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