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  1. www.ecfr.gov › current › title-21eCFR :: 21 CFR 820.3 -- Definitions.

    Chapter I —Food and Drug Administration, Department of Health and Human Services; Subchapter H —Medical Devices; Part 820 —Quality System Regulation; Subpart A —General Provisions § 820.3

  2. www.fda.gov › regulatory-information › search-fda-guidance-documentsClassification of Products as Drugs and Devices and Additional...

    Conceptually, all FDA-regulated medical products meet the definition of “drug” under section 201(g) of the FD&C Act, due to the broader scope of the drug definition.

  3. www.fda.gov › medical-devices › device-advice-comprehensive-regulatory-assistanceOverview of Device Regulation | FDA

    The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation...

  4. www.fda.gov › medical-devices › overview-device-regulationClassify Your Medical Device | FDA

    Overview of Device Regulation. Classify Your Medical Device. The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of...

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  6. www.ecfr.gov › current › title-21eCFR :: 21 CFR Chapter I Subchapter H -- Medical Devices

    Title 21. Food and Drugs. Part / Section. Chapter I. Food and Drug Administration, Department of Health and Human Services. 1 – 1299. Subchapter H. Medical Devices. 800 – 898.

  7. www.fda.gov › industry › importing-fda-regulated-productsImporting Medical Devices | FDA - U.S. Food and Drug...

    The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part...

  8. www.fda.gov › medical-devices › products-and-medical-proceduresProducts and Medical Procedures | FDA

    Oct 5, 2023 · The FDA regulates medical devices sold in the United States to assure their safety and effectiveness. Medical devices range from simple tongue depressors and hospital gowns to complex...

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