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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 300.750 Class III Devices Subject to 515(b) Requirements July 2005

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Devices and Radiological Health

This compliance policy guide describes class III devices subject to requirements of Section 515(b) of the Federal Food, Drug, and Cosmetic Act.


Submit Comments

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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