Mar 16, 2018


  • FDA 510(k) applicants may receive Refuse to Accept (RTA) letters if their submissions are not complete, delaying their medical device clearance reviews.
  • Meeting RTA screening criteria can help medical device registrants avoid receiving RTA letters from FDA reviewers.
  • Utilizing the FDA Pre-Submission (Pre-Sub) program prior to submitting 510(k) applications may also minimize the risk of clearance delays due to RTA issues.

Top 5 reasons for receiving an FDA RTA letter for your 510(k) applicationBefore a medical device company’s 510(k) premarket notification submission to the US Food and Drug Administration undergoes substantive review, the agency reviews the submission for completeness according to its Refuse to Accept (RTA) policy.

FDA 510(k) applicants should ensure that their submissions meet RTA screening criteria to avoid RTA letters that can delay their US market commercialization plans. Below, we discuss some of the most common reasons 510(k) registrants receive RTA letters, requiring additional premarket review times.

Five key reasons for receiving an FDA RTA letter

  1. Failure to comply with FDA guidance: Applicants should adhere to recommendations listed in the agency’s guidance documents on formatting Traditional, Special and Abbreviated 510(k) submissions. Some device sponsors may not understand how to compile and format their 510(k) submissions.
  2. Failure to supply an eCopy: FDA 510(k) applicants must submit an electronic (eCopy) of their 510(k) applications to the agency.
  3. Failure to understand the difference between different types of 510(k)s: There are three types of premarket notification submissions: Traditional (most common), Special (less common) and Abbreviated (rare). Some applicants do not understand the differences between these types of 510(k)s and submit the wrong type, which prompts an RTA letter during the FDA’s administrative review process.
  4. Failure to identify FDA guidance applicable to your device: In their submissions, 510(k) applicants should identify FDA guidance documents if applicable to their devices’ specific product code. If such information has not been included in a submission, FDA reviewers will deem your submission lacking.
  5. Failure to provide test data applicable to your device: Virtually all 510(k) applications submitted for FDA review must include some type of test data (e.g., electromagnetic compatibility (EMC), electrical safety, sterilization, biocompatibility, shelf-life, mechanical performance, etc.) or require other verification and validation documentation if, for instance, the device contains software in it; if the device could be affected by cybersecurity threats, or if human factors engineering plays a critical role in the operation and use of the device. However, many 510(k) registrants may not be aware that they must include this information in their submissions.

To avoid submitting incomplete 510(k) applications that result in RTA letters from FDA—or Additional Information (AI) request from FDA once the substantive review of the 510(k) starts—medical device companies should consider the agency’s Pre-Submission Program (or Pre-Sub) whereby applicants can discuss various issues of the 510(k) submission for their devices with the FDA before making their final submission. By doing this in advance, the device applicant can significantly increase the chances of having their device cleared with few to no requests by the FDA for additional information, and thereby have their devices cleared sooner.    

Related FDA 510(k) and RTA resources from Emergo:


  • Stuart Goldman and Stewart Eisenhart