November 27, 2018 / 2:18 AM / in 4 months

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saying the “modern” framework will provide an alternative review procedure for a process frequently criticized as outdated and unsafe.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

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below