04/26/2022

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The US Food and Drug Administration (FDA) released a guidance “Refuse to Accept Policy for 510(k)s” in April 2022. This guidance was originally issued in May 1994 and was previously updated in September 2019. The guidance describes the procedures the FDA uses to determine if a medical device premarket notification (510(k)) meets the minimum threshold of acceptability for their regulatory review. The purpose of an acceptance review is to determine if it is a quality submission containing all the items required. This step is done prior to the FDA reviewing the content of the notification to help streamline the process, thus ensuring the FDA meets the performance goals required under the Medical Device User Fee Amendments of 2017 (MDUFA IV). The guidance clarifies that the acceptance review is specifically for determining the application is complete and is not reviewing the quality of any trial specific or other supporting data. This process is applicable for all medical devices that go through the 510(k) notification process, including Traditional, Abbreviated, or Special 510(k)s.

Under the Refuse to Accept policy, the FDA informs the entity submitting the 510(k) within 15 calendar days if the submission does not meet the acceptance criteria. The entity can complete the missing items under the same submission, unless requested to resubmit. Once the FDA verifies the application is complete, it notifies the submitting entity and begins the determination of substantial equivalence of the medical device. This process is outside the scope of this guidance, but the guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” from July 2014 explains this further.

The regulations for 510(k) premarket notification are detailed in 21 CFR 807.87 to 807.100 and include the items needed for regulatory submission. The checklists in the following appendices list theses needed components. The FDA recommends that the submitting entity complete and include the checklist with the submission.

Appendix A. Acceptance Checklist for Traditional 510(k)s
Appendix B. Acceptance Checklist for Abbreviated 510(k)s
Appendix C. Acceptance Checklist for Special 510(k)s

Other guidance “Format for Traditional and Abbreviated 510(k)s”, “The Abbreviated 510(k) Program”, and “The Special 510(k) Program” all from September 2019 may be helpful for submitting entities in preparing their 510(k) premarket notifications.

-The Clinical Pathways Team

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