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Health Canada is creating a stand-alone Medical Devices Directorate (MDD) within its Health Products and Food Branch that will take a “lifecycle approach” and also take on postmarket functions currently within the Marketed Health Products Directorate. Read More
Sens. Chuck Grassley (R-Iowa), Elizabeth Warren (D-Okla.) and three representatives urged the Centers for Medicare & Medicaid Service to begin including information from unique device identifiers (UDIs) for high-risk implants on electronic insurance claims. Read More
The proposal by Australia’s Therapeutic Goods Administration to align its regulation of software as a medical device with the EU’s approach drew general support from stakeholders, with some also urging the agency to look at approaches by the International Medical Device Regulators Forum, the FDA and Health Canada. Read More
The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to sponsors who wish to submit a 510(k) application using the agency’s Safety and Performance Based Pathway. Read More
The FDA released final guidance for devicemakers laying out the information it provides when it denies export certificate requests and the steps firms should take to appeal rejections. Read More
The proposed revision would clarify that certain Class I devices that had a conformity assessment before May 26, 2020 could be placed in the market until May 26, 2024. Read More