On April 25, 2022 the U.S. Food and Drug Administration (FDA) updated the 2019 final guidance: Refuse to Accept Policy for 510(k)s. The minor updates and clarifications include:
- Correction of broken links
- Providing additional clarity that devices ineligible for 510(k) (for example, a device type classified in class III requiring PMA) may be refused by the FDA
The acceptance checklists were not substantively changed in this update.
The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review. Focusing the 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.
Comments can be submitted to the FDA online or in writing on any guidance at any time (see 21 CFR 10.115(g)(5)). Written comments should be sent to the below address and should be identified with docket number: FDA-2012-D-0523:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
For more information on the FDA process for 510(k)s, please email us at: firstname.lastname@example.org and ref:. FDA 510(k) process.