November 27, 2018 / 2:18 AM / in 22 days

FDA announces 'modernized' medical device clearance process

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saying the “modern” framework will provide an alternative review procedure for a process frequently criticized as outdated and unsafe.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.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2PYkFY4

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