US FDA Provides 510(k) Communication Timeline
The US Food and Drug Administration recently added a new timeline to its 510(k) premarket notification webpage that summarizes typical communications between agency reviewers and medical device applicants between submission and final clearance.
The FDA published its new chart to meet 510(k) performance goals set up by the Medical Device User Fee Amendments of 2012 (MDUFA III). The chart indicates a 90-day timeframe for most 510(k) clearance decisions, and spells out what manufacturers can expect in terms of possible communications with FDA reviewers during their US medical device registration process.
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