Uniform Contraceptive Device Labeling for Pregnancy and STD Protection Information
This guidance provides recommendations for uniform labeling of all contraceptive devices regarding protection from pregnancy and sexually transmitted diseases (STDs). It aims to consolidate previous recommendations into a single document to ensure consistent labeling information for consumers and healthcare professionals.
Recommended Actions
- Review current device labeling against the guidance requirements
- Update pregnancy rate tables using the FDA-recommended format
- Implement appropriate STD protection statements based on device type
- Ensure both consumer and professional labeling contain required information
- Submit appropriate regulatory documentation for any STD protection claims for diaphragms or cervical caps
- Verify that all effectiveness data is current and matches the latest clinical data
- Ensure all warning statements are prominently displayed and easily readable
- Maintain documentation of compliance with labeling requirements
- Implement a process for periodic review of labeling to ensure continued compliance with the guidance
Key Considerations
Labelling
- Include an easy-to-read table with pregnancy rates for all contraceptive methods
- Provide specific STD protection statements based on device type:
- IUDs and tubal occlusion devices
- Natural skin condoms
- Latex condoms for men
- Male condoms made from new materials
- Female condoms
- Diaphragms and cervical caps
- Include pregnancy rate information in both “Typical Use” and “Lowest Expected” scenarios
- Present comparative information on pregnancy rates of various contraceptive products
- Include STD protection statements in both consumer and professional labeling where applicable
Safety
- Clearly communicate the device’s ability or inability to protect against STDs
- Include specific warnings about HIV/AIDS protection capabilities
- Provide clear statements about pregnancy prevention effectiveness
Other considerations
- No claims for STD protection for diaphragms or cervical caps without appropriate 510(k) or PMA supplement submission
- Include comparative information to help users understand the effectiveness of their chosen contraceptive method
Relevant Guidances
- Testing and Labeling Requirements for Non-Latex Male Condoms
- Male Latex Condoms - Abbreviated 510k Submissions Using Consensus Standards
- Device Labeling Requirements and Content for Premarket Approval Applications
Original guidance
This post is licensed under CC BY 4.0 by the author.