The Emergo Group reports that the U.S. Food and Drug Administration recently added a new timeline to its 510(k) premarket notification webpagesummarizing typical communications between agency reviewers and medical device applicants for the period between submission and final clearance.
The FDA’s new chart is intended 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 theirUS 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.