Medical Devices
Read the FDA’s New Discussion Paper on Artificial Intelligence and Machine Learning-Based Software as a Medical Device.
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Artificial Intelligence and Machine Learning in Software as a Medical Device FDA Safety Communication
- The FDA Warns Against Use of Previously Owned Test Strips or Test Strips Not Authorized for Sale in the United States.
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The FDA Warns Against Use of Previously Owned Test Strips or Test Strips Not Authorized for Sale in the United States: FDA Safety Communication FDA Safety Communication
- The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion.
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The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion: FDA Safety Communication Reorganization of The Center for Devices and Radiological Health CDRH is reorganizing to create an agile infrastructure that can adapt to future organizational, regulatory and scientific needs. -
Reorganization of The Center for Devices and Radiological Health
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Device Advice: Comprehensive Regulatory Assistance CDRH Learn Recent Final Medical Device Guidance Documents Recent Draft Medical Device Guidance Documents - Premarket Requirements (How to Market Your Device)
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CDRH Strategic Priorities and Updates Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety Reorganization of The Center for Devices and Radiological Health
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CDRH-Center for Devices and Radiological Health
Food and Drug Administration
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