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  1. Center for Devices and Radiological Health | FDA

    In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health by assuring that patients and …

  2. FDA Center for Devices and Radiological Health - Wikipedia

    The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health …

  3. Whether or not a premarket application or approval is required, an innovator seeking to market a medical device in the U.S. is required to register and list the device with the FDA as well as …

  4. CDRH Offices | FDA

    Jan 5, 2023 · FDA's Center for Devices and Radiological Health has eight offices that cover the total product lifecycle of regulated medical devices and radiation-emitting products.

  5. Available today: CDRH’s 2024 Annual Report

    Jan 17, 2025 · Available today: CDRH’s 2024 Annual Report U.S. Food and Drug Administration sent this bulletin at 01/17/2025 09:47 AM EST

  6. FDA Center for Devices and Radiological Health (CDRH)

    The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate both medical devices and …

  7. CDRH Overview

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  8. A Busy Day in the (CDRH) Neighborhood: Updates to the CDS and …

    5 days ago · On January 6, 2026, FDA issued two revised guidance documents related to clinical decision support (CDS) software and low-risk general wellness products. In a video …

  9. CDRH Learn | FDA

    Sep 30, 2025 · CDRH Webinars feature FDA presentations and live stakeholder question and answer discussions about timely medical device laws, regulations, guidances, or programs.

  10. CDRH Portal enhancements allow users to do more online.

    The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has updated the Customer Collaboration Portal (commonly called the CDRH Portal) …