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The final rule applies to data that supports investigational drug exemption applications, 510(k) submissions and de novo classification requests, as well as applications for premarket approval, product development protocols and humanitarian device exemptions. Read More
DOJ claimed that Mid Atlantic Cardiovascular Associates sent Union Memorial hospital referrals for profitable cardiovascular procedures for Medicare-covered patients. Read More
Australia’s TGA released five new draft guidances that propose changes to the classification of numerous medical devices to align more closely with European Union regulations. Read More
CDRH warned that more than 100 device manufacturers and hundreds of devices face potential shortages following an EPA order to stop medical equipment sterilizer Sterigenics’ Willbrook, Illinois facility from sterilizing products with ethylene oxide. Read More
The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and in vitro diagnostic regulations. Read More
The Medical Imaging & Technology Alliance is calling on the FDA to establish a framework that distinguishes between servicing and remanufacturing activities for medical imaging devices. Read More
Australia’s Therapeutic Goods Administration reached the end of its three-year transition period to the 2016 version of ISO 13485 and devicemakers using the updated standard to show Quality Management System (QMS) conformity are now expected to have their systems up-to-date. Read More
The FDA issued a proposed rule aimed at modernizing mammography quality standards and better positioning the agency to act when violations are found. Read More
The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed rulemaking issued April 2. Read More
The FDA issued a new draft guidance laying out how the agency is updating uniform inspections—other than for-cause inspections—to reflect the FDA Reauthorization Act of 2017. Read More