Share on Facebook
Share on Twitter
Share on LinkedIn

The U.S. Food and Drug Administration on Monday announced a new path for medical device manufacturers to receive product clearance, saying the “modern” framework will provide an alternative review procedure for a process frequently criticized as outdated and unsafe.

FDA Commissioner Scott Gottlieb’s long-awaited announcement marks an overhaul of the agency’s existing fast-track pathway, known as the 510(k) clearance process.

Read More