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Your Digital Health Regulation Questions Answered - Healthcare

The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD).

Digital health policy navigatorOffice of the national coordinatorOffice of combination productsOffice for civil rightsDigital health frequently asked questionsHealth app interactive toolHealth breach notification ruleDrug administrationRadiological healthWhat you needHealth policy navigatorPremarket approvalMobile health app interactive toolNational coordinatorCivil rightsFederal trade commission

Your Digital Health Regulation Questions Answered | Fenwick & West LLP

regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD)..

Digital health policy navigatorDigital health frequently asked questionsRadiological healthDrug administrationOffice of the national coordinatorHealth app interactive toolHealth breach notification ruleFenwick westOffice of combination productsOffice for civil rightsHealth policy navigatorPremarket approvalMobile health app interactive toolNational coordinatorCivil rightsFederal trade commission

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