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How to Determine if Your Product is a Medical Device

    https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

    Aesthetic (Cosmetic) Devices | FDA - U.S. Food and …

      https://www.fda.gov/medical-devices/products-and-medical-procedures/aesthetic-cosmetic-devices
      Aesthetic (Cosmetic) Devices. Aesthetic (cosmetic) devices may be used to help achieve your desired effect. However, a procedure may not always give you the …

    Dermal Fillers (Soft Tissue Fillers) | FDA - U.S. Food and …

      https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/dermal-fillers-soft-tissue-fillers
      En español. Dermal fillers, also known as injectable implants, soft tissue fillers, lip and facial fillers, or wrinkle fillers are medical device implants approved by the FDA for use in …

    Is My Product a Medical Device? - Food and Drug …

      https://www.fda.gov/media/131268/download
      Definition of a Medical Device Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act) defines a device as:

    Differences Between Cosmetics and Medical Devices

      https://www.fda.gov/cosmetics/warning-letters-related-cosmetics/warning-letters-highlight-differences-between-cosmetics-and-medical-devices
      Warning Letters Highlight Differences Between Cosmetics and Medical Devices. FDA warning letters issued to manufacturers and/or distributors of devices …

    Food, Drug and Medical Device | Sidley Austin LLP

      https://www.sidley.com/en/global/services/food-drug-and-medical-device/
      In-Depth. Sidley’s global Food, Drug and Medical Device practice represents major biopharmaceutical, biotechnology, medical device, food, cosmetic, dietary …

    Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) - U.S.

      https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
      The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, …

    FD&C Act Chapter V: Drugs and Devices | FDA - U.S.

      https://www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-v-drugs-and-devices
      Part A - Drugs and Devices (sections 351 - 360n-1) Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products. Sec. 355c - Research …

    To amend the Federal Food, Drug, and Cosmetic Act to …

      https://www.govtrack.us/congress/bills/118/hr1090
      H.R. 1090: To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness. Track H.R. …

    Classification of Products as Drugs and Devices and …

      https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues
      FDA-2011-D-0429. Issued by: Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products. Additional copies are available from: Office …



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