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FDA to improve device review procedures
In an effort to expedite the availability of new medical devices, the FDA’s Center for Devices and Radiological Health has undertaken an independent evaluation of its review process, the agency said in a press release.In the evaluation — part of the 2012 Medical Device User Fee Amendments (MDUFA III) — the Center for Devices and Radiological Health (CDRH) engaged a third-party consulting firm to analyze the CDRH’s review process, management systems, IT organization, workload management methods, reviewer training and staff turnover.