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Submissions for radiation biodosimetry medical countermeasure devices should include well-controlled analytical studies establishing device performance across the entire range of the device, the FDA says. Read More
Companies assuming possession of a previously cleared 510(k) device would have 30 days to register the transfer of ownership on an FDA online database, under draft guidance released late last month. Read More
EU leaders are deadlocked over a proposed premarket mechanism for the highest-risk devices, and the stalemate threatens to delay adoption of a major overhaul in device and diagnostic regulations until late next year or even 2016. Read More