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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cleared 510(k) device would have 30 days to register the transfer of ownership on an FDA online database, under draft guidance released late last month.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
The FDA last week green-lighted a new test for coronary heart disease, saying it could be especially helpful in detecting the condition in African-American women. Read More
Proof that a diagnostic test could be safely performed by untrained workers convinced the FDA to grant a first-ever regulatory waiver for a syphilis rapid screening assay. Read More
Manufacturers of passive implants, such as surgical screws, must begin subjecting products to magnetic resonance testing to see if they become dangerous when exposed to MR systems and radiofrequency heating, the FDA says. 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