Menstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Resumo

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Menstrual Products-- Performance Testing and Labeling Recommendations." This draft guidance document provides recommendations for performance testing, labeling, and information for inclusion in premarket notification (510(k)) submissions, when necessary, for certain menstrual products. The recommendations in this guidance apply to 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 product labeling and testing for manufacturers of these devices. This draft guidance is not final nor is it for implementation at this time.