Canada: New Medical Devices Directorate established at Health Canada
Canada: Final guidance published on Software as a Medical Device (SaMD)
USA: Stephen Hahn takes over as FDA Commissioner
USA: President Trump repeals medical device excise tax
USA: US Court disagrees with FDA’s classification of a device as a drug
USA: New rules for cranial electrotherapy stimulator devices for treating anxiety and/or insomnia, and for treating depression
USA: Orthopaedic surgical instrumentation designed for osteochondral implants with press-fit fixation classified as Class II (special controls)
USA: Class II classification appropriate for internal therapeutic massagers
USA: Class II classification for radiological CADx software for lesions suspicious for cancer
USA: Radiological computer aided triage and notification software has been classified into Class II (special controls)
USA: Reclassification of medical image analysers, including CADe devices
USA: Class II classification deemed appropriate for self-fitting air-conduction hearing aids
USA: Exemption from pre-market notification for powered wheeled stretchers
USA: List of Class I and Class II devices exempt from pre-market notification
USA: Five types of Class II devices proposed for exemption from 510(k) requirements
USA: Continuous glucose monitor data management systems classified into Class I
USA: All pre-market applications now require only a single submission in electronic format
USA: Guidance outlines process for seeking a review of a denial of a CFG
USA: Performance criteria proposed for MR coils to support Safety and Performance Based Pathway
USA: Requesting FDA feedback on combinations products – draft guidance circulated for comment
USA: Guidance drafted on 510(k) submissions for peripheral percutaneous transluminal angioplasty and specialty catheters
USA: Guidance drafted on bridging for drug-device and biologic-device combination products
USA: FDA’s regulatory agenda for 2020
USA: CDRH announces new steps to advance innovation in device sterilisation using EtO
USA: FDA recognises more than 100 new standards, including ISO 14971: 2019
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