Tag: CDRH

FDA Adds 5 Regulatory Science Tools to Help Assess Medical Devices

The U.S. Food and Drug Administration (FDA) added 5 tools to the Catalog of Regulatory Science Tools to help assess medical devices. This catalog collates a variety of over 80 regulatory science tools developed by the Office of Science and Engineering Labs (OSEL) in the FDA’s Center for Devices and Radiological Health (CDRH). New tools […]

The FDA issues Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan

On 01/12/2021, the U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence. The Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework […]

FDA adds 25 regulatory science tools to help assess medical devices

The U.S. Food and Drug Administration (FDA) added 25 tools to the Catalog of Regulatory Science Tools to help assess medical devices. The tools include: Laboratory Accuracy Evaluation of Infrared Thermographs Benchmark Problems for Verifying Cardiac Electrophysiological Models Use of Newtonian Analog Fluids And 3D Printing to Evaluate Flow Rates of Diets In G-Tubes Confocal […]

FDA Launches the Digital Health Center of Excellence

The U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). This center will further the agency’s dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and […]

New from CDRH

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 24, 2019. To view listings for other dates, see CDRH New – News and Updates. Federal Register: Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants with Press-Fit Fixation Federal Register: Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic […]

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