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.
What You Need to Know? 👇
What are the key biocompatibility requirements for non-latex condoms?
Non-latex condoms must demonstrate biocompatibility through cytotoxicity, sensitization (polar and nonpolar extracts), mucosal irritation, acute systemic toxicity, mutagenicity, and implantation (90 day) testing on the finished product.
How many condoms are needed for slippage and breakage studies?
FDA recommends at least 1000 uses of each condom type (test and control) with sufficient couples enrolled to ensure each uses 3-5 condoms of each type in a randomized crossover design.
What is the minimum detection limit for viral penetration testing?
The test must detect 2 x 10⁻⁶ ml penetration of challenge virus suspension using a titer of 1 x 10⁸ pfu/ml with 95% confidence detection capability.
How long should contraceptive effectiveness studies run?
Contraceptive effectiveness studies should include at least six completed menstrual cycles of product use, with approximately 400 couples enrolled per arm to achieve 300 completed couples per arm.
What interim labeling is required during post-market efficacy studies?
The principal display panel must state “For Latex Sensitive Condom Users” and include warnings that pregnancy and STD risks are unknown while studies are ongoing, with reference to latex condom effectiveness.
What manufacturing process information must be submitted in a 510(k)?
Submissions must include detailed flow diagrams, process control parameters, batch sizes, quality control testing points, handling procedures for failed products, and complete descriptions of manufacturing equipment and procedures including mandrels and sealing processes.
What You Need to Do 👇
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 ID: 7610d2477e8591e440172d613ed3b54c