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

    https://www.fda.gov/Medical-Devices
    CDRH News and Events Medical Device Safety Device Advice Public Health Emergency Updates Stay up to date as we continue to keep up our ongoing mission of protecting public health and...

Center for Devices and Radiological Health | FDA

    https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
    In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and …

Send and Track Medical Device Premarket Submissions …

    https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal

    Center for Devices and Radiological Health (CDRH) …

      https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/center-devices-and-radiological-health-cdrh-compliance-programs
      Sep 15, 2020

    Device Registration and Listing | FDA

      https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
      Device Registration and Listing | FDA Device Registration and Listing Owners or operators of establishments that are involved in the production and distribution of …

    Guidance Documents (Medical Devices and Radiation …

      https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
      CDRH Guidance Development SOP (PDF - 165KB) Center for Devices and Radiological Health Standard Operating Procedure (SOP) - Level 1, Immediately in Effect Guidance …

    CDRH Learn | FDA - U.S. Food and Drug Administration

      https://www.fda.gov/training-and-continuing-education/cdrh-learn
      Welcome to CDRH Learn, the FDA Center for Devices and Radiological Health's (CDRH) web page for multimedia industry education. CDRH Learn is our innovative educational …

    Establishment Registration & Device Listing - Food and …

      https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm
      medical device manufacturers registered with FDA and medical devices listed with FDA Note: Registration of a device establishment, assignment of a registration …

    Recognized Consensus Standards - Food and Drug …

      https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
      Databases This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity. After FDA …



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