GUIDANCE DOCUMENT
Menstrual Products - Performance Testing and Labeling Recommendations Draft Guidance for Industry and Food and Drug Administration Staff October 2025
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2025-D-5107
- Docket Number:
- FDA-2025-D-5107
- Issued by:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document provides the FDA’s recommendations for performance testing, labeling, and information for inclusion in premarket notification (510(k)) submissions, when necessary, for certain menstrual products. The devices subject to the recommendations in this guidance include tampons, pads, and menstrual cups used to absorb or collect menstrual fluid or other vaginal discharge. The recommendations reflect updated review practices and are intended to promote consistency and transparency in menstrual product labeling and testing recommendations for manufacturers of these devices.