fda guidance tampons

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The Facts on Tampons—and How to Use Them Safely | FDA- fda guidance tampons ,Sep 30, 2020·The Facts on Tampons—and How to Use Them Safely. Tampons cleared by the FDA are meant to be used one time and then thrown away. No tampon should be used more than once.Guidance for Industry and FDA Staff - Menstrual …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) requirements.



CPG Sec. 345.300 Menstrual Sponges | FDA

Jul 01, 1981·Sea sponges labeled as "menstrual sponges," "hygienic sponges," or "sanitary sponges," intended for use as menstrual tampons, are regarded as …

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Menstrual Tampons and Pads: Information for ... - FDA

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) requirements.

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

Aug 25, 2021·The FDA’s guidance documents addressing when a digital health solution, including OTC and patient-facing software, meets the definition of device and is the focus of the FDA’s regulation ...

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Medical Devices; Labeling for Menstrual Tampon for the ...

The cleaning instructions provided for the COHITECH Reusable Tampon Applicator . were developed per the recommendations in the 2015 FDA guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and . K212479 Page 3 of 4

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