What causes an FDA 510k Refuse to Accept (RTA) decision?

An FDA 510(k) "Refuse to Accept" (RTA) decision is a procedural determination that a submission is administratively incomplete and cannot be accepted for substantive review. This initial screening occurs within the first 15 calendar days after the FDA receives the submission. It is crucial to understand that an RTA is not a rejection of the device's safety, effectiveness, or scientific merit. Instead, it is a gatekeeping step to ensure the submission package meets all organizational and formatting requirements outlined in FDA's policies and guidance documents before the detailed review begins. Receiving an RTA can cause significant delays. When a 510(k) is "refused," the 90-day review clock stops, and the sponsor must correct all identified deficiencies before formally resubmitting the entire application. The most common reasons for an RTA are often administrative oversights, such as missing forms, an incorrectly formatted eCopy, or failing to include sections clearly required by FDA guidance. Therefore, preventing an RTA requires meticulous preparation and a thorough audit of the submission against the FDA’s official RTA checklist before it is sent. ### Key Points * **Administrative, Not Substantive:** An RTA decision is based on the completeness and formatting of the submission, not a judgment on the device's approvability. * **15-Day Initial Review:** The FDA makes an RTA determination within the first 15 calendar days of receiving a 510(k) submission. * **Common Triggers:** Frequent causes include missing forms (like the MDUFA user fee form), eCopy technical failures, an absent table of contents, or failure to include information specified in a relevant guidance document. * **Significant Delays:** An RTA stops the review clock entirely. The sponsor must address all deficiencies and resubmit the application, restarting the entire process. * **Prevention is Key:** The most effective strategy to avoid an RTA is to carefully review the submission against the FDA’s current 510(k) RTA checklist before submission. ### Understanding the RTA Process and Common Pitfalls The FDA's RTA policy is designed to conserve agency resources by ensuring that only complete and well-organized submissions enter the more intensive substantive review phase. To facilitate this, the FDA publishes a detailed RTA checklist that reviewers use to assess each incoming 510(k). If a submission fails to meet these administrative criteria, it will be returned to the sponsor with a list of the deficiencies. #### Common Administrative Reasons for an RTA Decision While the checklist is comprehensive, certain issues appear more frequently than others. Sponsors should pay close attention to the following areas: 1. **Missing or Incomplete Forms:** A 510(k) submission requires several administrative forms, and the omission or incorrect completion of any one of them can trigger an RTA. A common example is the Medical Device User Fee Act (MDUFA) Cover Sheet. For current FDA user fee information, sponsors should consult the FDA website at https://www.fda.gov/industry/fda-user-fees. 2. **eCopy Formatting Issues:** The FDA has specific technical standards for electronic submissions. An eCopy that is not searchable, contains broken links, is not structured correctly, or fails validation will be refused. 3. **Organizational Deficiencies:** Simple organizational mistakes are a frequent cause of RTAs. This includes a missing table of contents, failure to number pages, or not labeling sections according to the recommended 510(k) format. This makes it difficult for the reviewer to navigate the submission and confirm its completeness. 4. **Failure to Address Applicable Guidance:** If an FDA guidance document clearly applies to the device type (e.g., cybersecurity guidance for connected devices), the submission must include the information requested in that guidance. Omitting a required section, such as cybersecurity or biocompatibility testing, is a clear basis for an RTA. 5. **Inadequate Predicate Information:** The submission must clearly identify a primary predicate device and provide a comprehensive comparison. If the predicate information is missing or the comparison table is incomplete, the FDA cannot begin its substantial equivalence review. ### Scenario 1: The SaMD Submission with Missing Cybersecurity Information **Scenario:** A company develops a Class II Software as a Medical Device (SaMD) that connects to a hospital network to retrieve patient data. The 510(k) submission includes strong performance data and a detailed device description. However, the sponsor overlooks the FDA's guidance on cybersecurity and fails to include a dedicated cybersecurity section outlining risk management and mitigation strategies. **Outcome:** The submission receives an RTA decision. The FDA reviewer, using the RTA checklist, notes the absence of required cybersecurity documentation, which is considered a critical component for this type of device. The review clock is stopped, and the company must develop the required documentation and resubmit the entire 510(k) package. ### Scenario 2: The Diagnostic Device with an eCopy Failure **Scenario:** A manufacturer submits a 510(k) for a new in-vitro diagnostic test kit. The scientific content is robust, and all necessary forms are included. However, the final eCopy was created by scanning paper documents into a single, non-searchable PDF file. **Outcome:** The submission receives an RTA. The FDA's technical standards require a searchable PDF with a clear table of contents and bookmarks. Because the reviewer cannot electronically search or navigate the document, the submission is deemed administratively incomplete. The sponsor must reformat the entire submission to meet the eCopy technical standards and resubmit. ### Strategic Considerations and the Role of Q-Submission The best strategy for avoiding an RTA is proactive preparation. This involves conducting a rigorous internal audit of the final 510(k) draft against the FDA’s most current RTA checklist. Assigning a team member who was not involved in writing the submission to perform this check can help identify oversights. While a Q-Submission (Pre-Submission) meeting is typically used to discuss scientific or clinical questions, it can indirectly help prevent an RTA. By engaging with the FDA early, sponsors can gain clarity on the agency's expectations for testing and documentation. This feedback ensures that the final 510(k) submission will contain all the necessary sections and data types the FDA expects to see, reducing the risk of an RTA for an obviously missing component. However, a Q-Submission does not replace the need for a careful administrative review before final submission. ### 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 administrative complexities of a 510(k) submission requires exceptional organization. Tools like Cruxi can help teams manage regulatory documentation, track submission requirements against checklists, and create a structured framework for the entire 510(k) package. By centralizing documents and using built-in templates aligned with regulatory standards, teams can reduce the risk of common administrative oversights that lead to an RTA, ensuring the submission is complete and properly formatted before it reaches the FDA. 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.