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

## How Long Does FDA 510(k) Review Take in 2024? When planning the commercialization of a new Class II medical device, sponsors often focus on the FDA's 510(k) review timeline. While the FDA has established performance goals for review, the total time from submission to clearance can vary significantly based on the quality of the submission and the complexity of the device. The most common misconception is that the 510(k) review is a single, continuous 90-day period. In reality, the process includes several phases where the review "clock" can pause, most notably for administrative checks and requests for more information. The total calendar time to achieve 510(k) clearance in 2024 is not a fixed number but is directly influenced by FDA interactions. The two most significant factors that extend the timeline are the initial Refuse to Accept (RTA) review and subsequent Additional Information (AI) requests. If a submission is incomplete, the review clock is paused until the sponsor provides the missing information. Understanding these stages and preparing a comprehensive submission is the most effective strategy for achieving a predictable and efficient review. ### Key Points * **FDA Goal vs. Calendar Time:** The FDA's performance goal is to make a MDUFA decision on 510(k) submissions within 90 calendar days, but this does not include time the submission is on hold pending a response from the sponsor. * **The "Clock" Stops:** The review clock pauses during the initial administrative Refuse to Accept (RTA) review if the submission is incomplete. It also stops if the FDA issues an Additional Information (AI) request during the substantive review. * **Submission Quality is Critical:** A complete, well-organized 510(k) that anticipates potential questions is the single most important factor in minimizing delays and achieving clearance closer to the 90-day goal. * **RTA is the First Hurdle:** Before substantive review begins, the FDA conducts an administrative check. Failing this RTA review places the submission on hold immediately, delaying the start of the primary review process. * **AI Requests Add Significant Time:** If the FDA requires more data or clarification, they will issue an AI request. The time a company takes to gather data and formulate a complete response is entirely in its control and adds directly to the total project timeline. ### Understanding the Stages of 510(k) Review The 510(k) review process is not a single, uninterrupted period. It is a multi-stage process where the timeline is contingent on both FDA actions and the sponsor's responses. #### The FDA's 90-Day Goal: What It Really Means Under the Medical Device User Fee Amendments (MDUFA), the FDA has a performance goal to review and act on 510(k) submissions within 90 calendar days. However, this refers to "FDA days"—the time the submission is actively under review at the agency. This 90-day clock is paused whenever the FDA places the submission on hold to await information from the sponsor. Therefore, the total time from submission to final decision is often longer than 90 days. #### Stage 1: The Refuse to Accept (RTA) Review Within the first 15 calendar days of receipt, the FDA performs an administrative review using an RTA checklist. This is not a scientific review but a check to ensure the submission is complete and formatted correctly according to FDA guidance. * **What FDA Will Scrutinize:** Common RTA triggers include missing forms, incomplete device descriptions, failure to identify a valid predicate, or absent testing data required by guidance documents. * **Impact on Timeline:** If the submission is found incomplete, the FDA will issue an RTA hold. The review clock stops, and it will not restart until the sponsor submits all the required information. This initial hold can add weeks or months to the timeline before the substantive review even begins. #### Stage 2: Substantive Review and the Additional Information (AI) Hold Once a submission passes the RTA stage, it moves to substantive review. During this phase, an FDA reviewer conducts a detailed scientific and regulatory assessment to determine if the new device is substantially equivalent to its predicate. * **What FDA Will Scrutinize:** The reviewer will assess everything from the device's indications for use and technological characteristics to the performance data (bench, animal, and clinical, if applicable). If any aspect is unclear, or if the data provided is insufficient to establish substantial equivalence, the FDA will issue an AI request. * **Impact on Timeline:** When an AI request is sent, the 90-day review clock stops. The sponsor typically has a set period (e.g., 180 days) to respond. The clock does not restart until the sponsor submits a *complete* response that addresses all of the FDA's questions. The time spent gathering this additional data is often the most significant contributor to extending the total 510(k) timeline beyond the 90-day goal. ### Scenario 1: A Straightforward Submission * **Device Example:** A Class II software as a medical device (SaMD) for analyzing diagnostic images, with a clear predicate and well-established technology. * **What FDA Will Scrutinize:** The sponsor provides comprehensive software documentation, verification and validation testing, and a clear comparison to the predicate. The submission is well-organized and follows all relevant FDA guidance. * **Timeline Impact:** The submission passes the RTA review without issue. During substantive review, the FDA has no major questions, and the submission proceeds smoothly. The total time to clearance is close to the 90-day FDA review goal. ### Scenario 2: A Review with an AI Hold * **Device Example:** A Class II orthopedic implant made with a novel surface material intended to improve osseointegration. * **What FDA Will Scrutinize:** While the core implant design is similar to the predicate, the new material raises questions about biocompatibility and long-term mechanical performance. * **Timeline Impact:** The submission passes RTA, but during substantive review, the FDA issues an AI request for additional biocompatibility data and mechanical fatigue testing. The review clock stops. The sponsor takes 75 days to complete the new tests and submit a full response. The total calendar time becomes approximately 165 days (90 FDA review days + 75 sponsor response days). ### Strategic Considerations and the Role of Q-Submission The most effective strategy for a predictable 510(k) timeline is to minimize the chances of an RTA or AI hold. This is achieved by preparing a high-quality, comprehensive submission that leaves no room for ambiguity. For devices with novel features, new materials, or unclear testing requirements, engaging the FDA *before* filing the 510(k) is a critical de-risking step. The Q-Submission program allows sponsors to request feedback from the FDA on their regulatory strategy, including the choice of predicate and plans for performance testing. This early feedback can help identify and resolve potential review issues ahead of time, dramatically increasing the likelihood of a smooth and efficient 510(k) review. ### 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).