Medical device

FDA Review Process for 510(k)

A guide on the FDA 510(k) review process

April 11, 2022
Rory A. Carrillo
Principal Consultant

Medical device manufacturers submitting 510(k) applications to the US Food and Drug Administration typically have questions regarding review timelines and communication channels as they await clearance decisions from the regulator.

FDA has provided details addressing such questions on its 510(k) premarket notification webpage that summarized typical communications between agency reviewers and medical device applicants between submission and final clearance. FDA’s 510(k) webpage now also reflects the timeline that medical device and in vitro diagnostic (IVD) device manufacturers can currently expect when submitting registration applications to the agency.

510(k) Review Communication Timeline

The FDA originally published its 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.