Issue Date: April 7, 1987
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket, Premarket,
Status: Final

All U.S. Condom Manufacturers, Importers and Repackagers

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.

Download the Guidance Document