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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The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison.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 sent a warning letter to American Contract Systems for process validation violations at its Houston, Texas medical device manufacturing and sterilizing facility. 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
CDRH released a list of priority guidances it plans to publish during fiscal 2020, including numerous quality-related final and draft guidances. Read More
The FDA hit six devicemakers for a range of compliance failures observed during facility inspections, including lax acceptance procedures and missing records. Read More