fda cfr tampons requirements

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Code of Federal Regulations (CFR) | FDA- fda cfr tampons requirements ,Code of Federal Regulations (CFR) FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & …Guidance for Industry and FDA Staff - Menstrual …Guidance for Industry and FDA Staff . Menstrual Tampons and Pads: ... requirements of the applicable statutes and regulations. If you want to discuss an alternative ... (Under 21 CFR 807.87(l), FDA



21 CFR § 801.430 - User labeling for menstrual tampons ...

Electronic Code of Federal Regulations (e-CFR) Title 21 - Food and Drugs; CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SUBCHAPTER H - MEDICAL DEVICES; PART 801 - LABELING; Subpart H - Special Requirements for Specific Devices § 801.430 User labeling for menstrual tampons.

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CFR - Code of Federal Regulations Title 21 - Food and Drug ...

Oct 01, 2021·For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 884.5470 Unscented menstrual tampon. (a) Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal ...

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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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CFR - Code of Federal Regulations Title 21

Oct 01, 2021·CFR - Code of Federal Regulations Title 21. The information on this page is current as of April 1 2020. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 801.430 User labeling for menstrual tampons. (a) This section applies to scented or scented deodorized menstrual tampons as ...

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CFR - Code of Federal Regulations Title 21 - Food and Drug ...

Oct 01, 2021·This information is current as of Oct 01, 2021.. This online reference for CFR Title 21 is updated once a year. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).. This database includes a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal …

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

Aug 25, 2021·Menstrual Tampons and Pads: ... The FDA’s regulations in 21 CFR Part 801, subpart C, set forth specific requirements for labeling OTC devices. In …

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CFR - Code of Federal Regulations Title 21 - Food and Drug ...

Oct 01, 2021·For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 884.5460 Scented or scented deodorized menstrual tampon. (a) Identification. A scented or scented deodorized menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used ...

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CFR - Code of Federal Regulations Title 21 - Food and Drug ...

Oct 01, 2021·CFR - Code of Federal Regulations Title 21. The information on this page is current as of Oct 01, 2021. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor. § 801.3 - Definitions.

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