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.
Recommended Actions
- Complete all preclinical testing before initiating clinical studies
- Submit IDE application for significant risk device investigations
- Conduct feasibility study to evaluate preliminary performance
- Perform slippage and breakage study with adequate sample size
- Conduct contraceptive effectiveness study (can be post-market)
- Develop and validate consumer labeling
- Generate comprehensive biocompatibility data package
- Document detailed manufacturing process controls
- Establish quality control testing procedures
- 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
- Detailed manufacturing process information required
- Package integrity specifications needed
- Barrier properties/permeability testing required
Relevant Guidances
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Shelf Life and Stability Testing for Medical Devices
- Import Surveillance and Detention Process for Condoms Failing Water Leak Testing Requirements
Related references and norms
- 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.