Barrier Devices for STD Protection During Oral Sex - Requirements for 510k Submissions
This guidance outlines the regulatory requirements for barrier devices intended for protection from sexually transmitted diseases (STDs) during oral sex. The FDA has reclassified these devices from requiring a PMA to requiring a 510(k) premarket notification, aligning them with other barrier devices like condoms, exam gloves, and surgical gowns.
Recommended Actions
- Contact FDA’s Obstetrics and Gynecologic Devices Branch to discuss specific testing requirements
- Prepare 510(k) submission including:
- Complete device description and intended use
- Identification of predicate device and comparison
- In-vitro barrier integrity testing data
- Biocompatibility data for patient-contacting materials
- Sterilization validation if applicable
- Human factors data if required by design
- Comprehensive labeling
- Submit 510(k) notification and wait for FDA clearance before marketing
- Ensure compliance with all manufacturing and quality system requirements
- Maintain documentation of all testing and validation activities
- Consider conducting limited distribution for investigational use to gather clinical information if needed
Key Considerations
Non-clinical testing
- Must provide bench testing data to establish adequate performance under simulated use conditions
- Must include in-vitro studies to demonstrate barrier integrity with respect to STD microorganisms
- Testing methodology should be adapted from FDA’s condom barrier testing protocol
Human Factors
- May require data to demonstrate that users can safely and effectively place the device depending on design
Labelling
- Must include intended use statement
- Must include caution statement as per 21 CFR 801.109(b)(1)
- Must provide complete device description and directions for use
Biocompatibility
- Must provide biocompatibility information for all patient-contacting materials
- Testing should be conducted on sterilized final devices
- Alternative: certification that materials are identical to predicate device
Safety
- Must demonstrate adequate barrier properties against STD transmission
- Must establish sterility if device is labeled as sterile
- Must provide sterility assurance level (SAL) and validation of sterilization method
Other considerations
- Must identify legally marketed predicate device
- Must provide comparison of technological characteristics to predicate
- Must submit 510(k) summary or statement as per SMDA requirements
Relevant Guidances
- Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
- Medical Device Product Code Usage and Requirements
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Testing and Labeling Requirements for Non-Latex Male Condoms
Related references and norms
- ASTM D 3578-77: Standard Specification for Rubber Examination Gloves
Original guidance
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