Regulatory Requirements for Condom-Like Products and Novelty Condoms
This guidance clarifies FDA's policy regarding condom-like products (novelty condoms) and establishes that any product that can cover the penis with a closely fitting membrane and has the appearance of a condom is considered a condom, regardless of its marketing or labeling as a novelty item.
Recommended Actions
- Review product design and characteristics to determine if it meets the definition of a condom
- If product meets condom definition:
- Implement leak testing procedures
- Ensure compliance with GMP regulations
- Complete manufacturer registration
- Submit product listing
- Obtain pre-market notification clearance
- If marketing novelty products:
- Ensure products are physically altered to be unusable as condoms
- Document modification method
- Review all product labeling to ensure compliance
- Establish quality control procedures for leak testing
- Maintain documentation of regulatory compliance
Key Considerations
Non-clinical testing
- Must comply with specific condom leak testing requirements
Labelling
- Labeling a functional condom as a novelty is not sufficient to exempt it from regulatory requirements
Safety
- Products must comply with Good Manufacturing Practices regulations
Other considerations
- Manufacturer registration required
- Product listing required
- Pre-market notification and clearance required
- To be considered non-regulated, condom-like products must be rendered completely unusable (e.g., removing closed end, shredding sides, sealing roll)
Relevant Guidances
- Testing and Labeling Requirements for Non-Latex Male Condoms
- Male Latex Condoms - Abbreviated 510k Submissions Using Consensus Standards
- Import Surveillance and Detention Process for Condoms Failing Water Leak Testing Requirements
Related references and norms
- 21 CFR 884.5300: Condom classification regulation
Original guidance
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