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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
The FDA expressed concerns about their clinical validity, noting that it was “unaware of data establishing the relationships between the genotypes assessed…and assertions regarding drug response for multiple drugs. 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