Issue Date: February 23, 1994
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket, Premarket,
Status: Final
Letter – Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter – Manufacturers, Distributors and Importers of Condom Products
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. 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.
Download the Guidance Document
