fda tampons information system

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Menstrual Tampons and Pads: Information for ... - FDA- fda tampons information system ,1. Introduction. FDA has developed this guidance document to assist industry in preparing premarket notification submissions (510(k)) for menstrual tampons and pads that are subject to 510(k ...Guidance for Industry and FDA Staff - Menstrual …Menstrual Tampons and Pads: Information for Premarket ... call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a ... FDA may request additional information . 3. If FDA …

Over-the-Counter (OTC) Medical Devices - fda.gov

Aug 25, 2021·Menstrual Tampons and Pads: Information for ... or analyze a medical image or signal from an in vitro diagnostic device or pattern or signal from a signal acquisition system. The FDA has …

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The Facts on Tampons—and How to Use Them Safely | FDA

Sep 30, 2020·Tampons are medical devices regulated by the U.S. Food and Drug Administration. If you or a loved one uses them, it's important to use them safely. …

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