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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.

  1. Review product design and characteristics to determine if it meets the definition of a condom
  2. 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
  3. If marketing novelty products:
    • Ensure products are physically altered to be unusable as condoms
    • Document modification method
  4. Review all product labeling to ensure compliance
  5. Establish quality control procedures for leak testing
  6. 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

  • 21 CFR 884.5300: Condom classification regulation

Original guidance

  • Regulatory Requirements for Condom-Like Products and Novelty Condoms
  • HTML / PDF
  • Issue date: 1994-02-23
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket, Premarket
  • ReguVirta summary file ID: db1b49b73dac0208b62bed5b6cd984fb
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