Surveillance and Detention Without Physical Examination of Condoms Guidance for Industry and FDA Staff July 2008

GUIDANCE DOCUMENT

• Docket Number: FDA-2000-D-0137
• Issued by: Center for Devices and Radiological Health

Consumers rely on condoms for protection from HIV (AIDS) and other sexually transmitted diseases (STDs), as well as for contraception. Because condom defects, such as holes, can compromise the effectiveness of the condom barrier and pose a potentially significant hazard to the health of users, FDA samples condoms and performs water leak testing as described in Compliance Policy Guide CPG 7124.21.

FDA’s Center for Devices and Radiological Health (CDRH) is aware from its import records that some foreign manufacturers and shippers repeatedly attempt to import condoms that fail water leak testing (i.e., they do not meet the acceptable quality criteria defined in CPG 7124.21, based on the number of defective condoms in the samples). To address the issue, FDA proposed a strategy for import surveillance and detention in the draft guidance made available on August 14, 2000. FDA is making available this final guidance document to provide guidance to FDA staff and industry regarding FDA’s strategy for addressing further imports of condoms from manufacturers/shippers whose condoms have failed to meet FDA’s minimum acceptable quality criteria.

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