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Medical Device Safety Action Plan: Protecting Patients, …

    https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health
    In the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, the FDA describes key actions it will take in the following areas: Establish a robust medical device patient safety net in the United States Explore regulatory options to streamline …

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

    https://www.fda.gov/medical-devices/medical-device-safety
    Medical Device Safety | FDA Medical Device Safety The FDA monitors …

The Role of the FDA in Ensuring Device Safety | PSNet

    https://psnet.ahrq.gov/perspective/role-fda-ensuring-device-safety

    AHA Backs Bill for Device Tracking System - Becker's Hospital …

      https://www.beckershospitalreview.com/quality/aha-backs-bill-for-device-tracking-system.html
      The American Hospital Association has expressed its support of the proposed bipartisan Ensuring Safe Medical Devices for Patients Act. AHA Backs Bill for Device Tracking …

    Overview of Regulatory Requirements: Medical Devices

      https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
      Within FDA, the Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary …

    Legislation Would Require Automatic Device Tracking to Improve …

      https://www.beckershospitalreview.com/quality/legislation-would-require-automatic-device-tracking-to-improve-device-safety.html
      Senators Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wis.) have introduced the bipartisan Ensuring Safe Medical Devices for …

    Senators Introduce Bipartisan Effort to Make Medical …

      https://www.merkley.senate.gov/news/press-releases/senators-introduce-bipartisan-effort-to-make-medical-devices-safer
      The Ensuring Safe Medical Devices for Patients Act would implement long overdue reforms and help save lives Thursday, March 15, 2012. Washington, DC – …

    Senators Introduce Bipartisan Effort to Make Medical …

      https://www.grassley.senate.gov/news/news-releases/senators-introduce-bipartisan-effort-make-medical-devices-safer
      The bill would give the Food and Drug Administration the tools it needs to improve oversight of medical devices. Defective medical devices have been associated …

    Senators Introduce Bipartisan Effort to Make Medical …

      https://www.bennet.senate.gov/public/index.cfm/2012/3/senators-introduce-bipartisan-effort-to-make-medical-devices-safer
      Today, Colorado U.S. Senator Michael Bennet, along with Senators Jeff Merkley (D-OR), Chuck Grassley (R-IA), and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe …

    Preventing Medical Device Shortages by Ensuring Safe …

      https://www.fda.gov/news-events/fda-voices/preventing-medical-device-shortages-ensuring-safe-and-effective-sterilization-manufacturing
      For instance, medical devices made from certain polymers (such as plastic or resin), metals, or glass—or devices that have multiple layers of packaging or hard-to-reach …



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