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# Menstrual Products Testing, Labeling Guidance
- URL: https://www.fdaweb.com/menstrual-products-testing-labeling-guidance/
- Published: 2025-10-28T12:00:00.000Z
- Updated: 2026-09-14T15:25:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160122

FDA has published a draft guidance, *Menstrual Products—Performance Testing and Labeling Recommendations*, with the agency’s recommendations for performance testing and labeling of such products, and also information for inclusion in 510 (k) submissions, when necessary, for certain menstrual products. The [document](https://www.fda.gov/media/189362/download?ref=fdaweb.com) says its recommendations apply to tampons, pads, and menstrual cups used to absorb or collect menstrual fluid or other vaginal discharge.

“The recommendations reflect updated best practices for the labeling and performance testing of menstrual products, as well as current review practices for menstrual products subject to premarket notification requirements,” the guidance says. “These recommendations are intended to promote consistency and transparency in product labeling and testing for manufacturers of these devices.”

The guidance contains an Introduction, Background, Scope, Predicate Comparison (Devices Subject to 510(k) Requirements), Device Description in the 510(k) or Device Master Record, Performance Testing Recommendations, Labeling Recommendations, and Modifications (Devices Subject to 510(k) Requirements).