Issue Date: April 21, 2022
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Administrative / Procedural
Status: Final
Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff
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 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.
Download the Guidance Document
