April 11, 2018 / 2:46 PM / 7 months ago

BRIEF-FDA To Offer Voluntary, More Modern 510(K) Pathway For Moderate Risk Devices

April 11 (Reuters) - FDA:

* U.S. FDA TO OFFER VOLUNTARY, MORE MODERN 510(K) PATHWAY FOR ENABLING MODERATE RISK DEVICES TO MORE EFFICIENTLY DEMONSTRATE SAFETY AND EFFECTIVENESS

* PROPOSED NEW OPTION FOR 510(K) CLEARANCE WHICH ALLOWS MANUFACTURERS TO USE OBJECTIVE PERFORMANCE CRITERIA

* PROPOSED OPTION ALLOWS MANUFACTURERS TO USE CERTAIN CRITERIA TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE OF NEW PRODUCTS TO LEGALLY MARKETED DEVICES

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