美国FDA 指导原则 所有美国避孕套制造商、进口商和分装商(仅限PDF) 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 updated m thn revision to include the standardelernents of GGP7s. - . $5 ,- \O %J - . .r DEPAltT.\l E N T OF HEALTH H U A I A N SERVICES 7 06 q. Pubk Health Snvice - - . . Food and Omg Administration APR 71981: - . . Rockvilla MO 20857 To: A11 U.S. Condom Manufacturers, Importers and Repackagers . . - . Because o f t h e heightened i n t e r e s t i n reducing t h e r i s k s o f a c q u i r i n g s e x u a l l y transmitted diseases (STOs), i n c l u d i n g Acquired Immune Oef i c i ency Syndrome (AIDS) ,t h e Food and Drug Administration ( F D A ) i s p r d v i d i n g t h i s guidance t o manufacturers, importers and repackagers o f condoms.