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GUIDANCE DOCUMENT

All U.S. Condom Manufacturers, Importers and Repackagers April 1987

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

Because of the heightened interest in reducing the risks of acquiring sexually transmitted diseases (STDs), including Acquired Immune Deficiency Syndrome (AIDS), the Food and Drug Administration (FDA) is providing this guidance to manufacturers, importers and repackagers of condoms.

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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