美国FDA 指导原则 信纸制造商避孕套产品分销商及进口商(包括在避孕套包装398内)(只有PDF格式) 英文原版.pdfVIP

This guidance was written prior to the February 27, 1997 implementation of FDAs Good Guidance Practices, GGPs. 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 willbe up dated in the next revision to include the standard elemnts of GGPs . DEPARTMENT OF HEALTH HUMAN SERVICES Pubtic Health Service 8 Food and Drug Administration Center for Devices and RadiilogicaiH 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 (STDs), especially AIDS. Therefore, condoms or products that canbe 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 belie