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2023 Safety Communications | FDA

    https://www.fda.gov/medical-devices/safety-communications/2023-safety-communications
    The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient...

CDRH Proposed Guidances for Fiscal Year 2023 …

    https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2023-fy2023

    Medical Device Safety | FDA - U.S. Food and Drug …

      https://cacmap.fda.gov/medical-devices/medical-device-safety
      The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices …

    Medical Device Safety | FDA - U.S. Food and Drug …

      https://www.fda.gov/medical-devices/medical-device-safety
      Medical Device Safety The FDA monitors reports of adverse events and other …

    Medical Devices | FDA - U.S. Food and Drug Administration

      https://www.fda.gov/Medical-Devices
      FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical …

    Public Calendar: January 29 - February 4, 2023 | FDA

      https://cacmap.fda.gov/news-events/public-calendar-meetings-fda-officials/public-calendar-january-29-february-4-2023
      Public Calendar: January 29 - February 4, 2023. This public calendar is issued by the Food and Drug Administration. It lists significant meetings held by …

    FDA Calendar – FDA Tracker

      https://www.fdatracker.com/fda-calendar/
      Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers all companies facing upcoming PDUFA dates. Streamline your research and quickly compare the relative timing of competing catalysts. All supporting data can be copied to the clipboard or …

    Devices Approved in 2023 | FDA

      https://www.fda.gov/medical-devices/pma-approvals/devices-approved-2023
      Devices Approved in 2023 Devices Approved in 2023 Share Tweet Linkedin Email Print This page lists all medical devices approved through the CDRH Premarket …

    Premarket Approval (PMA) - Food and Drug Administration

      https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
      Databases. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk …

    2023 Medical Device Recalls | FDA

      https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls
      2023 Medical Device Recalls | FDA An official website of the United States government Here’s how you know U.S. Food and Drug Administration Search Menu …



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