US regulators have warranted close attention from the QA/RA Blog since 2016 began. Using new 510(k) performance data from the FDA, Emergo has conducted an updated analysis of medical device clearance timeframes and related issues, as well as covered new agency initiatives for human factors and its Unique Device Identification (UDI) system.
Major US FDA-related news over the first several weeks of 2016 includes:
The agency has begun accepting Global Unique Device Identification Database (GUDID) account requests from Class II device labelers
