How to receiving an RTA (refuse to accept) from FDA on your 510(k) submission?

 FDA's current 510(k) Refuse to Accept (RTA) policy (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks) includes an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s). Our former FDA CDRH advise that using the RTA checklist (contained in the RTA policy guidance document), filling it completely with submission page numbers, and including that in the submission is an excellent and efficient way to avoid an RTA. They also recommend that Regulatory treat review of the submission like a design review, with a detailed cross-functional review of quality, completeness, and readability of the submission, including have an independent review provided by someone with fresh eyes on the documentation.


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