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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
The policy group argued that the tax narrowly targets profit margins of the medical device industry, which would ultimately stifle innovation. Read More
Listing the device would improve the quality of healthcare by enhancing tracking information on implants like cardiac stents and artificial joints, the lawmakers said. 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The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison.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