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Devices & Diagnostics Letter
Sept. 26, 2011 | Vol. 38 No. 38
510(k) Guidance Fallout, Review Clock Revamp Discussed in User Fee Talks
A possible tripling of the CDRH review workload and a revamped regulatory review clock were main topics of separate Medical Device User Fee and Modernization Act (MDUFMA) reauthorization meetings involving the FDA and device industry.
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