Menstrual Tampons and Menstrual Pads - Testing and Labeling Requirements for 510k Submissions
This guidance covers menstrual tampons and certain types of menstrual pads that require 510(k) submission. Specifically excluded are scented/unscented menstrual pads made of materials with established safety profiles that are not intralabial or reusable pads, as these are exempt from 510(k).
Recommended Actions
- Determine if your device requires 510(k) based on classification and exemption status
- Prepare detailed device description including:
- Engineering drawings and dimensions
- Materials and additives specifications
- Absorbency data for tampons
- Conduct required testing:
- Biocompatibility testing
- Performance testing
- Microbiology testing for tampons
- Clinical studies if needed
- Develop compliant labeling addressing all required elements
- Perform risk analysis and document risk mitigation measures
- Prepare 510(k) submission including all required testing data and documentation
- Consider pre-submission meeting with FDA for novel designs or materials
- Implement quality system controls for ongoing compliance
Key Considerations
Clinical testing
- Clinical studies may be needed for devices with:
- New designs/materials dissimilar from legally marketed devices
- New technology
- New indications for use
- For ultra absorbency tampons (15-18g), clinical data on fiber sloughing required
- Studies should evaluate: irritation, allergies, effects on vaginal microflora, abrasions, ulceration, laceration, residual fiber retention
Non-clinical testing
- Syngyna testing required for tampon absorbency determination
- String strength testing for tampons
- Fiber shedding evaluation for tampons
- Tampon integrity testing
- Chemical residue testing (dioxins, pesticides, herbicides)
Labeling
- Must comply with 21 CFR 801.430 for tampons
- Include product description and materials
- Instructions for selection, insertion, wear-time, removal and disposal for tampons
- TSS warning and 8-hour maximum wear time for tampons
- Allergic reaction warning for scented products
Biocompatibility
- Testing required per ISO 10993-1 for repeat use devices in contact with skin/mucosal membrane
- Tests appropriate for duration and level of contact
Safety
- Demonstrate tampons do not:
- Enhance S. aureus growth
- Increase TSST-1 production
- Alter normal vaginal microflora
Other considerations
- Complete device description including dimensions and engineering drawings required
- Component materials and additives must be detailed
- Risk analysis required to identify device-specific risks
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
Related references and norms
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Original guidance
This post is licensed under CC BY 4.0 by the author.