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.
Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.
REFERENCE: January 8, 2014; MassDevice; Stewart Eisenhart; Emergo Group