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  2. Wearable cardioverter defibrillator - Wikipedia

    en.wikipedia.org/wiki/Wearable_cardioverter...

    The WCD was extensively tested for three years in 17 major medical centers across the United States and Europe. The clinical data collected from those trials [26] allowed Lifecor to obtain FDA approval for use of the WCD in the United States. [citation needed] In 2001, the FDA approved the LifeVest wearable cardioverter defibrillator (model 2000).

  3. FDA Center for Devices and Radiological Health - Wikipedia

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

    The 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) enhanced FDA's ability to identify, prevent, and mitigate possible shortages of medical devices by requiring manufacturers to inform FDA of an interruption or permanent discontinuation of manufacturing during a public health emergency.

  4. List of COVID-19 pandemic legislation - Wikipedia

    en.wikipedia.org/wiki/List_of_COVID-19_pandemic...

    Second COVID-19 tier regulations in England; United States. Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 – March 2020;

  5. Stock up on KN95s after the updated CDC guidelines: These FDA ...

    www.aol.com/lifestyle/stock-kn95s-updated-cdc...

    Stock up on KN95s after the updated CDC guidelines: These FDA-approved masks are on sale for under $1.50 a pop at Amazon Devon Kelley,Izabella Zaydenberg August 9, 2021 at 6:00 AM

  6. FDA Alert on Hacking Vulnerability in Heart Defibrillators is ...

    www.aol.com/news/fda-alert-hacking-vulnerability...

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  7. Center for Biologics Evaluation and Research - Wikipedia

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

    Many of the products overseen by CBER are also considered drugs, and are subject to the same rules and regulations as any other drug product from the Food, Drug, and Cosmetic Act. [citation needed] From these legal authorities, CBER publishes regulations which are included in the first chapter Title 21 of the Code of Federal Regulations. Most ...

  8. FDA authorizes Novavax's updated COVID-19 vaccine - AOL

    www.aol.com/fda-authorizes-novavaxs-updated...

    Earlier this month, the health regulator approved updated COVID-19 vaccines made by Pfizer and Moderna targeting the KP.2 variant. JN.1 was the dominant strain in the United States earlier this year.

  9. 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 ...