Negotiations between industry and FDA are about to commence for the next round of medical device user fees, but the process for this round is already different from that of the first two iterations in that the agency held a public meeting on the subject. Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA, advised attendees that review times for 510(k) filings may be affected by the ongoing restructuring of the device clearance process, but he also said the agency is interested in feedback from all stakeholders, one of which argued that user fees are too low. (Medical Device Daily)
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