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).
What You Need to Know? 👇
What are the key requirements for 510(k) submissions for menstrual tampons and pads?
Submissions must include device description, risk analysis, performance characteristics, biocompatibility testing, and appropriate labeling. For tampons, additional requirements include absorbency testing using Syngyna method, chemical residue analysis, and microbiology testing for Staphylococcus aureus and TSST-1 production.
Which menstrual products are exempt from 510(k) requirements?
Scented or unscented menstrual pads made of materials with established safety profiles that are not intralabial pads or reusable menstrual pads are exempt from 510(k) requirements. These products fall under Class I classification with specific product codes.
What biocompatibility testing is required for menstrual tampons and pads?
Testing should follow ISO-10993 guidance for repeat use devices (30 days or more) in contact with skin/mucosal membrane surfaces. Select appropriate tests based on duration and level of contact. Identical materials in predicate devices may reference existing biocompatibility data.
When are clinical studies required for menstrual tampon 510(k) submissions?
Clinical studies may be required for devices with designs or materials dissimilar from legally marketed devices, new technology, or different indications for use. Studies should evaluate irritation, allergy, vaginal microflora effects, and tissue damage. Ultra-absorbency tampons require additional fiber sloughing evaluation.
What are the specific labeling requirements for menstrual tampons regarding TSS prevention?
Labels must limit wear-time to maximum 8 hours per tampon and advise against overnight use. Include TSS warning information per 21 CFR 801.430. For scented tampons, add allergic reaction warnings. Labeling should ensure consumer comprehension of safety information.
What modifications to legally marketed tampons require new 510(k) submissions?
New 510(k) required for: dissimilar indications, new materials/additives, dissimilar designs, or modifications achieving 15-18 gram absorbency. Changes in absorbent material ratios or adding non-ultra absorbency ranges generally don’t require new submissions but need documentation in design history files.
What You Need to Do 👇
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