FDAnews Device Daily Bulletin

Devices Can Keep Expedited Review Status After Competitor Approvals

March 11, 2008

Devices awaiting expedited review by the FDA will retain their status, even if another device for the same indication is approved first.

The agency had been revoking expedited status from all pending submissions after approving a device of the same type. It changed this practice to simplify the review process, according to a new guidance.

Under this new policy, if multiple applications for the same type of device are granted expedited review, they will be evaluated on a first-in, first-reviewed basis for each cycle.

Any application filed after the approval or clearance of a similar device will not be given expedited status unless the manufacturer is working with a federal agency to develop a device related to national security.

The guidance also eliminates three conditions for premarket approval (PMA) applications, modular PMAs or panel-track supplements under the first Medical Device User Fee and Modernization Act.

This guidance, which supersedes a 2003 guidance of the same name — “Expedited Review of Premarket Submissions for Devices” — is available at www.fda.gov/cdrh/mdufma/guidance/108.html.