What are the most common reasons for an RTA hold on a 510k?

Answering the Top Reasons for a 510(k) Refuse to Accept (RTA) Hold A Refuse to Accept (RTA) hold on a 510(k) submission can be a significant setback for medical device manufacturers. Issued within the first 15 days of receipt, an RTA decision indicates that the FDA has found the submission administratively or scientifically incomplete and cannot proceed with a substantive review. This initial checkpoint, governed by FDA's RTA policy, is not a rejection of the device itself but rather a determination that the dossier lacks the necessary components for a proper evaluation. Understanding the common pitfalls that lead to an RTA hold is critical for sponsors aiming for an efficient review process. These issues often extend beyond simple clerical errors, involving fundamental gaps in the predicate comparison, missing performance data summaries, or a failure to follow established FDA guidance. For devices ranging from diagnostic Software as a Medical Device (SaMD) to orthopedic implants, preparing a complete and well-organized submission is the first step toward a successful premarket notification. ### Key Points * **Purpose of RTA:** The RTA review is an administrative and completeness check, not a substantive scientific review of safety and effectiveness. Its goal is to ensure the submission is ready for evaluation. * **Incomplete Predicate Comparison:** A primary reason for an RTA hold is a missing or fundamentally flawed side-by-side comparison table that fails to address key aspects of intended use and technological characteristics. * **Missing Performance Data Summaries:** The complete absence of required data summaries—such as for biocompatibility, software validation, or testing specified in special controls—is a common trigger for an RTA decision. * **Administrative Deficiencies:** Simple mistakes like missing required FDA forms, incorrect formatting for the eCopy, or issues with user fee payment can halt a submission before it even begins. * **Failure to Address Guidance:** If a device falls under a specific FDA guidance document or has Class II special controls, the submission must clearly address the recommendations or requirements outlined in those documents. * **Proactive Planning is Key:** Many RTA holds are preventable through careful preparation, internal checklists, and, for complex issues, early engagement with the FDA via the Q-Submission program. ### Common RTA Triggers: A Closer Look An RTA hold can typically be traced back to deficiencies in one of three main areas: administrative elements, the predicate comparison, or the completeness of performance data. #### 1. Administrative and Formatting Deficiencies Before a reviewer even assesses the scientific content, the submission must pass a basic administrative screening. An RTA hold can be triggered by seemingly minor oversights. * **Missing Forms and Certifications:** The submission must include all required forms, such as the Premarket Review Submission Cover Sheet (FDA Form 3514). Certifications, like the Truthful and Accurate Statement, must also be present. * **eCopy Issues:** The electronic copy must adhere to FDA’s specific formatting and construction requirements. A poorly organized or technically non-compliant eCopy can be grounds for refusal. * **User Fee Payment:** While not part of the scientific review, failure to properly submit the required user fee can prevent the submission from being accepted. For current FDA user fee information, sponsors should consult the FDA website at https://www.fda.gov/industry/fda-user-fees. #### 2. Inadequate Predicate Device Comparison The foundation of a 510(k) is the claim of substantial equivalence (SE) to a legally marketed predicate device. The RTA review scrutinizes whether the submission provides a *complete* basis for this claim. * **What FDA Will Scrutinize:** The RTA review checks for the presence of a detailed, side-by-side comparison table that methodically compares the subject device to the predicate. This table must cover the intended use, indications for use, and all relevant technological characteristics (e.g., materials, design, energy source, performance specifications). An RTA is less likely to be triggered by minor differences—which are expected—and more likely by the complete absence of the comparison or a table that omits critical device features. * **Critical Information to Provide:** The submission must not only present the comparison but also include a clear discussion of why any differences do not raise new or different questions of safety and effectiveness. A submission that simply lists differences without providing a supporting scientific rationale is at high risk for an RTA hold. #### 3. Missing or Incomplete Performance Data While the substantive review will analyze the quality of performance data, the RTA review confirms its presence. A submission can be refused if it completely omits summaries of testing that are clearly necessary for the device type. * **What FDA Will Scrutinize:** The reviewer will check if the submission contains summaries for all applicable types of performance testing, including bench, animal, and clinical data where appropriate. For example, a 510(k) for a patient-contacting orthopedic screw system that lacks any mention of biocompatibility testing would likely be placed on RTA hold. Similarly, a submission for a diagnostic SaMD without a software validation section would be considered incomplete. * **Critical Performance Data to Provide:** Sponsors must ensure their submission includes data summaries that address requirements from relevant sources, including: * **Recognized Consensus Standards:** If a sponsor claims conformity to a standard, the necessary documentation must be included. * **FDA Guidance Documents:** Device-specific guidances often outline recommended testing. * **Class II Special Controls:** As identified under regulations like 21 CFR, some Class II devices have mandatory special controls that dictate specific performance requirements. A failure to address these is a major deficiency. ### Strategic Considerations and the Role of Q-Submission Avoiding an RTA hold begins with meticulous planning and organization. Using a detailed checklist based on FDA's RTA guidance is an essential practice for ensuring all administrative and content requirements are met before submission. For devices with novel features, complex technological characteristics, or challenging predicate comparisons, engaging the FDA early through the Q-Submission program can be a powerful risk-mitigation strategy. A Pre-Submission (Pre-Sub) meeting allows sponsors to present their proposed predicate rationale and testing plan to the FDA and receive feedback. This dialogue can clarify FDA's expectations, helping sponsors assemble a complete and reviewable 510(k) package and significantly reducing the likelihood of an RTA hold. ### 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 detailed requirements of a 510(k) submission can be complex. Tools like Cruxi can help sponsors organize their submission documents, manage checklists based on FDA guidance, and ensure all required elements are present before submission, helping to minimize the risk of administrative RTA holds. 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.