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  2. FDA Center for Devices and Radiological Health - Wikipedia

    en.wikipedia.org/wiki/FDA_Center_for_Devices_and...

    In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.

  3. Premarket tobacco application - Wikipedia

    en.wikipedia.org/wiki/Premarket_tobacco_application

    On May 10, 2016, the US FDA finalized its "deeming" rule, subjecting additional products to scrutiny under the Federal Food, Drug and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act. [4] The rule gives the US FDA authority to regulate e-cigarettes, cigars, and vape pens.

  4. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

  5. FDA Approves First OTC Hearing Aid Software Compatible With ...

    www.aol.com/fda-approves-first-otc-hearing...

    The FDA has approved the first over-the-counter (OTC) hearing aid software device for use with compatible versions of Apple Inc.’s (NASDAQ:AAPL) AirPods Pro headphones. Known as the Hearing Aid ...

  6. Center for Drug Evaluation and Research - Wikipedia

    en.wikipedia.org/wiki/Center_for_Drug_Evaluation...

    FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.

  7. FDA Approves ClearPoint Neuro's Updated Software For Guidance ...

    www.aol.com/news/fda-approves-clearpoint-neuros...

    The FDA granted 510(k) clearance for ClearPoint Neuro Inc's (NASDAQ: CLPT) version 2.1 of the ClearPoint Neuro Navigation software. Version 2.1 of the ClearPoint System is intended to provide ...

  8. Center for Biologics Evaluation and Research - Wikipedia

    en.wikipedia.org/wiki/Center_for_Biologics...

    In 2002, the FDA transferred a number of biologically produced therapeutics to CDER. [8] CBER regulates a number of biologics-related products, including blood tests, computer software, and devices related to blood transfusion, which industry representatives would like to see handled by the much brisker Center for Devices and Radiological ...

  9. Center for Food Safety and Applied Nutrition - Wikipedia

    en.wikipedia.org/wiki/Center_for_Food_Safety_and...

    The Center for Food Safety and Applied Nutrition (CFSAN (/ ˈ s ɪ f ˌ s æ n / SIF-san)) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA. [3]

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