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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).

  1. Determine if your device requires 510(k) based on classification and exemption status
  2. Prepare detailed device description including:
    • Engineering drawings and dimensions
    • Materials and additives specifications
    • Absorbency data for tampons
  3. Conduct required testing:
    • Biocompatibility testing
    • Performance testing
    • Microbiology testing for tampons
    • Clinical studies if needed
  4. Develop compliant labeling addressing all required elements
  5. Perform risk analysis and document risk mitigation measures
  6. Prepare 510(k) submission including all required testing data and documentation
  7. Consider pre-submission meeting with FDA for novel designs or materials
  8. 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

  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Original guidance

  • Menstrual Tampons and Menstrual Pads - Testing and Labeling Requirements for 510k Submissions
  • HTML / PDF
  • Issue date: 2005-07-26
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 9bb48d2d1e3fa6c393c2484c79440927
This post is licensed under CC BY 4.0 by the author.