Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom Products
Published: 1994-02-23
Status: Final Type: Guidance Document Category: Premarket (510(k) / PMA / De Novo / IDE) Topics: Postmarket, Premarket Docket: FDA-2020-D-0957
Official Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/letter-manufacturers-distributors-and-importers-condom-products-included-condom-packet-398 PDF: https://www.fda.gov/media/72114/download
Official Full Text
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 up dated in the next revision to include the standard elemnt s of GGP 's .
DEPARTMENT OF HEALTH & HUMAN SERVICES Pubtic Health Service Food and Drug Administration Center for Devices and Radiilogicai H e a b 2098 Gaither Road Rockville MD 20860 FEB 2 3 1994 qO: 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), Thie letter revioes and supersede8 that policy. Condoms are medical devices which many conapmers rely upon for contraception and prevention of eexually trbnemitted diseasee (STD's), especially AIDS. Therefore, condoms or products that can'be used as condoms, must comply with specific condom leak testing requirements as well as other regulatory requirements for medical devices. Some marketers have misinterpreted the 1989 policy and believe kt permits the marketing of condoms as novelty item even though they dp not comply with these requiremente. Theee novelty products frequbntly consist of a condom packaged or labeled for adult humor. They are traditionally sold in adult entertainment shops. This eituation has ca sed confusFon and may result in the use of these noncompliant products by ctnsumers with the expectation that they are effective in preventing pregnbncy and STDs. Products that can cover the penis with a closely fitting membrane and otherwise have the appearance of a condom are regarded as condoms regardless of packaging or labeling. These:producte, by form and function, meet the definition of a condom as defined in 21 CFR 884.5300 and must therefore comply with all requirements for condoms including leak testing, compliance with Good Manufacturing Practicep regulations, manufacturer registration, product listing, and pre-market notification and clearance. In order to market a condom-like product which is not subject to the above requiremente, the product cannot be usable as a condom in any way. For example, a condom could be rendered unusable by removing the cloeed end; shredding the aides; eealing the roll in ouch a way that' it cannot be unrolled, or.by some other method rendering.it equally unusable. Labeling a functional condom as a novelty is not sufficient. Questions concerning this policy can be directed to Mr. Byron L. Tart by writing to the letterhead address or phoning (301) 594-4639. Director Office of Compliance Center for Devices and FtadiolodJical Health