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GUIDANCE DOCUMENT

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

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, 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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.