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Cocaine and cocaine metabolite test systems are exempt from premarket notification procedures if they are intended for employment and insurance testing and say that on the labeling. Read More
The agency said electronic format includes eCopies, eSubmissions, and submissions created and submitted on CD, DVD or flash drive and mailed to the FDA. Read More
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The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison.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