Import Surveillance and Detention Process for Condoms Failing Water Leak Testing Requirements
This guidance outlines FDA's strategy for surveillance and detention of imported condoms that fail to meet quality requirements, particularly water leak testing criteria. It establishes a three-level risk-based detention process for managing imports from manufacturers/shippers whose condoms have failed FDA's minimum acceptable quality criteria.
Recommended Actions
- Implement water leak testing according to CPG 7124.21 requirements
- Establish process for proper sampling across different condom styles and cartons
- Maintain records of import history and detention levels for each manufacturer
- For detained shipments:
- Level 1: Submit 5 consecutive passing private lab test results
- Level 2: Submit 10 consecutive passing private lab test results
- Level 3: Demonstrate Quality System compliance through inspection/audit
- Review manufacturing procedures and practices if placed on detention
- Maintain documentation of all test results and corrective actions
- Submit proper documentation to FDA for removal from import alert when requirements are met
- Consider third-party audits to verify Quality System compliance if needed
Key Considerations
Non-clinical testing
- Water leak testing according to CPG 7124.21 sampling and testing requirements
- Testing by independent private laboratories in the US for release of detained shipments
- Multiple styles should not be mixed in one sample
- Representative sampling from several cartons required
Safety
- Condom defects like holes can compromise barrier effectiveness and pose significant health hazards
- One violative sample may be sufficient for detention due to potential health hazard
Other considerations
- Three-level detention process based on manufacturer’s import history
- Level 1: First violation - requires 5 consecutive passing shipments for removal
- Level 2: Second violation - requires 10 consecutive passing shipments for removal
- Level 3: Third violation - requires facility inspection/audit and quality system compliance
- 24-month surveillance cycle unless Level 3 detention occurs
- Quality System regulation compliance required for Level 3 removal
Relevant Guidances
- Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
- Testing Requirements for Metallic Plasma Sprayed Coatings on Orthopedic Implants
- Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522
Related references and norms
- 21 CFR Part 820: Quality System Regulation
Original guidance
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