Refusal to Accept Policy for 510(k)s
GUIDANCE FROM REFUSE TO ACCEPT POLICY FOR 510(K)S - GUIDANCE FOR INDUSTRY & FOOD & DRUG ADMINISTRATION STAFF
The updated (latest revision September 13, 2019) Refuse to Accept Policy for 510(k)s outlines procedures and criteria FDA intends to use in assessing Traditional, Abbreviated, and Special premarket notification (510(k)) submissions. Focusing FDA’s review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. The Refuse to Accept (RTA) policy includes an early review against specific acceptance criteria and serves 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).