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.
What You Need to Know? 👇
What are the FDA requirements for contraceptive device labeling regarding pregnancy rates?
All contraceptive devices must include an easy-to-read table showing pregnancy rates for their method and comparative rates for other contraceptive products. This table should use data from Contraceptive Technology and include both “typical use” and “lowest expected” pregnancy rates.
How should contraceptive devices be labeled for STD protection claims?
Labeling requirements vary by device type. IUDs and tubal occlusion devices must state they don’t protect against STDs. Latex condoms can claim STD protection if used properly. Natural skin condoms must recommend latex condoms for STD protection.
Can diaphragms and cervical caps claim STD protection in their labeling?
No, diaphragms and cervical caps cannot make STD protection claims without submitting appropriate 510(k) premarket notification or PMA supplement. Current clinical studies are inconclusive, and FDA hasn’t developed definitive uniform labeling statements for these devices.
What’s the difference between “typical use” and “lowest expected” pregnancy rates?
“Typical use” rates reflect real-world usage including incorrect use or inconsistent application. “Lowest expected” rates assume perfect, consistent use with every sexual encounter. Both rates must be included in contraceptive device labeling tables.
Are there specific labeling requirements for condoms made from new materials?
Yes, condoms made from new materials require interim labeling stating pregnancy and STD risks are unknown while studies are conducted. They must include laboratory test information and emphasize that latex condoms are highly effective for STD prevention.
What regulatory pathway is needed to add STD protection claims to contraceptive devices?
Manufacturers must submit a 510(k) premarket notification or PMA supplement with appropriate clinical data to support STD protection claims. The FDA hasn’t established uniform labeling for devices like diaphragms and cervical caps regarding STD protection.
What You Need to Do 👇
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 đź”—
- 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