What is the average FDA 510k review timeline in 2024?

## Understanding the FDA 510(k) Review Timeline in 2024: Beyond the 90-Day Goal For medical device manufacturers, one of the most critical planning questions is: "How long does the FDA 510(k) review process take?" While the FDA's performance goal under the Medical Device User Fee Amendments (MDUFA) is to make a MDUFA Decision within 90 calendar days, this figure represents 'FDA Days'—the time the submission is actively under review by the agency. The total elapsed time from submission to a final decision is often longer due to common "clock-stopping" events. Understanding the distinction between 'FDA Days' and 'Total Calendar Days' is essential for realistic project planning. The 90-day review clock can be paused for various reasons, most commonly when the FDA requires additional information from the sponsor. These pauses, which can last for weeks or months, mean that the journey to clearance frequently extends well beyond the 90-day target. Proactive planning and a high-quality initial submission are the best tools sponsors have to navigate this process efficiently. ### Key Points * **The 90-Day Goal is for 'FDA Days':** The widely cited 90-day 510(k) review timeline is an FDA performance goal, not a guaranteed clearance timeframe. It reflects the number of days the FDA actively reviews the file and does not include periods when the clock is stopped. * **'Clock-Stopping' Events Extend Timelines:** The review clock is paused when the FDA issues a request for Additional Information (AI). The clock only restarts once the sponsor submits a complete response, significantly extending the total calendar time to a decision. * **Refuse to Accept (RTA) Holds Prevent Review:** Before the substantive review even begins, a 510(k) submission undergoes an administrative review. If it is incomplete, the FDA can issue an RTA hold, and the 90-day review clock will not start until the deficiencies are addressed. * **Submission Quality is Paramount:** A well-organized, complete, and scientifically sound 510(k) submission is the most effective strategy to minimize the likelihood of RTA holds and major AI requests, thereby shortening the overall review timeline. * **Early FDA Engagement Can Prevent Delays:** Using the Q-Submission program to gain FDA feedback on testing plans or regulatory strategy before submitting the 510(k) can help prevent major questions during the review itself. ### Understanding 'FDA Days' vs. 'Calendar Days' The concept of the 'review clock' is central to the 510(k) process. According to FDA guidance, the agency has a performance goal to review most 510(k)s within 90 days. However, this clock is not a simple countdown. * **FDA Days:** This is the cumulative time the FDA is actively reviewing the submission. The clock runs from the day the submission is accepted for review until the day the FDA issues a decision or a request for more information. * **Calendar Days:** This is the total elapsed time from the initial submission date to the final MDUFA Decision (e.g., Substantially Equivalent). This period includes any time the review clock was paused while the sponsor prepared a response to an FDA request. For planning purposes, manufacturers must forecast based on total calendar days, as this reflects the true time-to-market. ### Common 'Clock-Stopping' Events Two primary events can pause or delay the start of the 510(k) review clock, significantly impacting the timeline. #### 1. Refuse to Accept (RTA) Holds Within the first 15 calendar days of receiving a 510(k), the FDA conducts an acceptance review based on a checklist to ensure the submission is administratively complete. If key elements are missing—such as a required form, the user fee payment, or essential sections of the submission—the FDA will issue an RTA hold. * **Impact:** An RTA decision stops the process before the 90-day substantive review clock even starts. The sponsor has 180 days to address the deficiencies and resubmit. This initial administrative hurdle can add weeks or months to the project timeline right from the start. #### 2. Additional Information (AI) Requests During the substantive review, FDA reviewers may determine that they need more information to reach a decision on substantial equivalence. This results in an AI request, which formally places the submission on hold. * **Impact:** An AI request stops the 90-day review clock. The sponsor is typically given 180 calendar days to provide a complete response. The clock remains paused during this entire period. For example, if the FDA issues an AI request on Day 60 of the review and the sponsor takes 90 days to respond, the total calendar time elapsed is already 150 days (60 + 90). The FDA clock will only restart at Day 60 upon receipt of the complete response. ### Strategic Considerations and the Role of Q-Submission To minimize delays and manage timelines effectively, sponsors should focus on two key areas: submission quality and proactive communication. A high-quality submission is the most direct way to avoid an RTA hold and reduce the likelihood of a major AI request. This includes ensuring all administrative requirements under 21 CFR regulations are met, the scientific rationale is clear, testing is comprehensive, and the substantial equivalence argument is well-supported. For devices with novel features, new technology, or complex testing requirements, early engagement with the FDA through the Q-Submission program is a valuable strategic tool. By discussing testing protocols or a proposed predicate device with the FDA *before* submitting the 510(k), sponsors can align with the agency's expectations. This proactive step can prevent major AI requests down the line, ultimately saving significant time and resources. ### Key FDA References - FDA Guidance: general 510(k) Program guidance on evaluating substantial equivalence. - FDA Guidance: Q-Submission Program – process for requesting feedback and meetings for medical device submissions. - 21 CFR Part 807, Subpart E – Premarket Notification Procedures (overall framework for 510(k) submissions). ## How tools like Cruxi can help Navigating the complexities of the 510(k) process requires meticulous organization and planning. Tools like Cruxi can help regulatory teams structure their submission narrative, manage evidence and documentation, and build a clear argument for substantial equivalence. By organizing data and linking it to regulatory requirements from the start, teams can improve the quality and completeness of their submission, helping to mitigate the risk of preventable delays like RTA holds or AI requests. This article is for general educational purposes only and is not legal, medical, or regulatory advice. For device-specific questions, sponsors should consult qualified experts and consider engaging FDA via the Q-Submission program.