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GUIDANCE DOCUMENT

Menstrual Products - Performance Testing and Labeling Recommendations Draft Guidance for Industry and Food and Drug Administration Staff October 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2025-D-5107
Issued by:
Guidance Issuing Office
Center 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This draft guidance document provides the FDA’s recommendations for performance testing, labeling, and information for inclusion in premarket notification (510(k)) submissions,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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-5107.

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