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Digital Health: Significant FDA Policy Developments In 2022 - Healthcare - Vimarsana News

Digital Health: Significant FDA Policy Developments In 2022 - Healthcare

Published: January 20, 2023

In 2022, FDA retreated from a flexible approach to its regulation of digital health in two key areas: (1) its PreCertification Program for software as a medical device (SaMD) and (2) its guidance...

Source: mondaq.com
Related Topics:
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FDA to regulate more AI & software tools as devices, guidance indicates - FDA also seeks new digital health regulatory paradigm in Pre-Cert Program report | Hogan Lovells - Vimarsana News

FDA to regulate more AI & software tools as devices, guidance indicates - FDA also seeks new digital health regulatory paradigm in Pre-Cert Program report | Hogan Lovells

Published: October 15, 2022

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to...

Source: jdsupra.com
Related Topics:
Clinical Decision Support SoftwareInternational Medical Device Regulators ForumCert Pilot ProgramDigital Health Policy NavigatorImage Communications DevicesSoftware Precertification PreDevice Software FunctionsDigital Health Software Precertification PreMedical Device Data SystemsMedical Image Storage DevicesMedical Image Communications DevicesMobile Medical ApplicationsDigital Health Software PrecertificationPilot ProgramCentury Cures ActFederal FoodCosmetic ActCures ActDecision Support SoftwareGeneral WellnessHealth PolicyMedical DeviceSoftware PrecertificationTest PlanExcellence Appraisals