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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 345.100 Condoms; Defects - Criteria for Direct Reference Seizure March 1995

Final

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

Center for Devices and Radiological Health

Office of Regulatory Affairs

This compliance policy guide describes FDA’s criteria for direct reference seizure of defective condoms.

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

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All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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