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In this section: Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Medical Device Reporting for User Facilities April 1996

Final

Docket Number:: FDA-2020-D-0957
Issued by:: Guidance Issuing Office

Center for Devices and Radiological Health

This guidance describes FDA’s policies on user facility medical device reporting requirements.

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-2020-D-0957.

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