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GUIDANCE DOCUMENT

Refuse to Accept Policy for 510(k)s Guidance for Industry and Food and Drug Administration Staff April 2022

Download the Final Guidance Document
Final
Docket Number:
FDA-2012-D-0523
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0523.

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