What is the FDA's timeline for responding to an RTA hold?

## What is the FDA's Timeline for Reviewing a 510(k) RTA Hold Response? After a medical device sponsor submits a 510(k) premarket notification, the submission first undergoes a Refuse to Accept (RTA) review. This is an initial administrative check to ensure the submission is complete and formatted correctly for a substantive review. If the FDA finds missing elements—such as a required testing summary or an incomplete device description—it will place the submission on an RTA hold. The sponsor then has up to 180 days to address the deficiencies. Once the sponsor submits a complete response to the RTA hold, a critical question arises: how long does the FDA take to review that response? Unlike the substantive review phase, **the FDA does not have a formal, publicly stated MDUFA performance goal or a dedicated review clock for assessing a response to an RTA hold.** This review is an administrative process to verify that all deficiencies noted in the RTA letter have been resolved. The main 90-day substantive review clock only begins after the FDA officially accepts the 510(k) for review. ### Key Points * **No Formal MDUFA Timeline:** There is no official, fixed MDUFA performance goal (e.g., 15 days, 30 days) for the FDA to review a sponsor's response to an RTA hold. * **Administrative Check:** The review of an RTA response is an administrative check for completeness, not a scientific or substantive review of the device's safety and effectiveness. * **Substantive Review Clock Starts After Acceptance:** The 90-day FDA review clock for a 510(k) does not begin until the submission is deemed complete and is formally accepted for substantive review. * **Sponsor's Responsibility:** The sponsor has a maximum of 180 calendar days to submit a complete response to an RTA letter. Failure to do so results in the submission being considered withdrawn. * **Focus on a Complete Response:** The most effective way to move past the RTA stage is to provide a clear, thorough, and point-by-point response that directly addresses every deficiency listed in the RTA letter. ### Understanding the 510(k) RTA Process The RTA policy, detailed in FDA guidance, is designed to ensure that agency resources are focused on complete submissions. Within the first 15 calendar days of receiving a 510(k), the FDA conducts an RTA review using a standardized checklist. A submission may be placed on RTA hold for various administrative reasons, including: * Missing user fees. * An incomplete eCopy or improperly formatted submission. * Failure to include required sections, such as a device description, labeling, or necessary performance data summaries. * Lack of a clear substantial equivalence argument. If the submission is found incomplete, the FDA issues an RTA hold letter detailing all the deficiencies. The review clock is paused, and the sponsor is given up to 180 days to provide the missing information. ### The RTA Response Review: What to Expect When a sponsor submits its response, the FDA's primary goal is to verify that the submission is now administratively complete. An FDA reviewer will compare the sponsor's response against the items listed in the original RTA hold letter. * **If the Response is Complete:** The FDA will issue an acceptance letter, which includes the official 510(k) number and the date of acceptance. This date marks Day 1 of the 90-day substantive review clock. * **If the Response is Still Incomplete:** The FDA may determine that the response did not adequately address all deficiencies. In this situation, the submission remains on hold. If the 180-day period expires, the submission is considered withdrawn, and the sponsor would need to resubmit the 510(k) as a new file. While there is no formal timeline for this administrative check, the duration can be influenced by factors like the reviewer's workload and the clarity of the sponsor's response. A well-organized response that clearly maps each provided item back to a specific deficiency in the RTA letter can facilitate a more efficient check. ### Strategic Considerations and the Role of Q-Submission The most effective strategy is to prevent an RTA hold in the first place. An RTA can introduce significant delays, as the 90-day review clock does not even start until the hold is resolved. Sponsors can take proactive steps to minimize the risk of an RTA: 1. **Thoroughly Review FDA Guidance:** Before submitting, carefully review FDA's "Refuse to Accept Policy for 510(k)s" guidance and the associated checklist. This document outlines exactly what the FDA looks for during the initial administrative review. 2. **Use the Q-Submission Program:** For novel devices or submissions with complex elements (e.g., a Class II SaMD with a new algorithm or an orthopedic implant with a novel material), engaging the FDA through a Pre-Submission (Q-Sub) is highly valuable. A Q-Sub allows sponsors to ask specific questions about testing plans and submission content, gaining alignment with the FDA on requirements before filing the 510(k). This can significantly reduce the chances of administrative incompleteness. 3. **Conduct an Internal Pre-Submission Audit:** Before filing, conduct a rigorous internal audit of the 510(k) submission against the FDA's RTA checklist to identify and correct any potential gaps. ### 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 a 510(k) submission requires careful organization and attention to detail. Tools like Cruxi can help regulatory teams structure their submission documents, manage evidence, and track requirements against FDA guidance and checklists. By providing a centralized platform for building a submission, these tools can help ensure all necessary components are included, reducing the risk of an administrative RTA hold and streamlining the path to a substantive review. *** *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.*