Critical Concepts Medical Device Software: Approaches to Determining Risk Classification, Qualification, and Safety and Performance Outcomes
In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic, the FDA released 4 guidance documents in 2022 alone, on topics ranging […]
Expert Opinion Panels and New Guidance Documents Are Part of the Changing Landscape of MDR 2017/745
Author: Suzanne Broussard, PhD | February 25, 2022 The European Union (EU) saw 2021 bring important milestones and changes to the implementation of Medical Device Regulation (MDR) 2017/745. Key highlights […]
Federal Court Rules that Some Imaging Agents Must be Classified as Medical Devices, Not Drugs
In case you missed it: in Genus Med. Techs., LLC v. FDA, 2021, Federal court rules that some imaging agents must be classified as medical devices, not drugs. Recently, the […]
