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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 300.400 Contamination of Devices Labeled as Sterile March 1995

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 FDA’s policy on contamination of devices labeled as sterile.

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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