CPG Sec. 345.100 Condoms; Defects – Criteria for Direct Reference Seizure

Issue Date: March 1, 1995
Issued by: Center for Devices and Radiological Health
Topic(s): Investigation & Enforcement, Administrative / Procedural
Status: Final

CPG Sec. 345.100 Condoms; Defects – Criteria for Direct Reference Seizure

This compliance policy guide describes FDA’s criteria for direct reference seizure of defective condoms.

Download the Guidance Document

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