Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Condoms; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Surveillance and Detention Without Physical Examination of Condoms." This guidance document provides information to FDA staff and industry about FDA's strategy for addressing further imports of condoms from manufacturers/shippers whose condoms have failed to meet FDA's minimum acceptable quality criteria. The guidance and the strategy are intended to help assure that condoms imported to the United States do not have defects that could compromise their effectiveness and present a health hazard to consumers who rely on condoms for protection from sexually transmitted diseases as well as for contraception.