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Testing and Labeling Requirements for Non-Latex Male Condoms

This guidance outlines testing requirements for male condoms made from new non-latex materials. It covers preclinical testing, clinical testing requirements, and labeling considerations for manufacturers seeking to market new material condoms through the 510(k) process.

  1. Complete all preclinical testing before initiating clinical studies
  2. Submit IDE application for significant risk device investigations
  3. Conduct feasibility study to evaluate preliminary performance
  4. Perform slippage and breakage study with adequate sample size
  5. Conduct contraceptive effectiveness study (can be post-market)
  6. Develop and validate consumer labeling
  7. Generate comprehensive biocompatibility data package
  8. Document detailed manufacturing process controls
  9. Establish quality control testing procedures
  10. Conduct shelf-life studies to support expiration dating

Key Considerations

Clinical testing

  • Initial feasibility study required to evaluate preliminary clinical performance and rule out immediate adverse effects
  • Slippage and breakage study with at least 1000 uses of each type condom required
  • Contraceptive effectiveness study with minimum 6 menstrual cycles required
  • Studies should be conducted in low-risk populations initially
  • At least two study centers should participate unless justified otherwise

Non-clinical testing

  • Physical testing required including:
    • Tensile strength
    • Force at break
    • Elongation
    • Tear resistance
    • Air burst volume/pressure
    • Water leakage
  • Viral penetration testing required using appropriate virus challenge
  • Shelf-life testing required through real-time or accelerated aging

Human Factors

  • Consumer understanding of labeling must be demonstrated
  • Studies must show target population can follow printed instructions
  • Special focus on users with limited education/literacy

Labelling

  • Must include “For Latex Sensitive Condom Users” on principal display panel
  • Must specify material type and that it is not latex
  • Must include important consumer information about risks and ongoing studies
  • Must include comparative information about latex condoms

Biocompatibility

  • Must provide biocompatibility data on finished product including:
    • Cytotoxicity
    • Sensitization
    • Mucosal irritation
    • Acute systemic toxicity
    • Mutagenicity
    • 90-day implantation

Safety

  • Material toxicity data required for all components
  • Manufacturing process controls must be documented
  • Quality control testing procedures must be detailed

Other considerations

  • IPPF Agreed Test: International Planned Parenthood Federation Agreed Test for Total Spermicidal Power

Original guidance

  • Testing and Labeling Requirements for Non-Latex Male Condoms
  • HTML
  • Issue date: 1995-06-28
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 7610d2477e8591e440172d613ed3b54c
This post is licensed under CC BY 4.0 by the author.