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GUIDANCE DOCUMENT

Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) Letter - Manufacturers, Distributors and Importers of Condom Products February 1994

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

This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.

TO: Manufacturers, Distributors and Importers of Condom Products

On February 13, 1989, the Food and Drug Administration (FDA) issued a statement of policy regarding the marketing of condom-like products (a.k.a."Novelty Condoms"). This latter revises and supersedes that policy.

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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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