FDA Is Revamping Clearance Procedures for Medical Devices
 

http://s.wsj.net/public/resources/im...1125192643.jpg

WASHINGTON—The Food and Drug Administration is significantly revamping the way it clears most medical devices for U.S. marketing, planning to rely far less on comparisons with much older products already on the market.

This reliance by the federal agency has been regarded as one of the weaknesses in the way it allows medical devices to be sold in the U.S., leading to problem devices like defective metal hip implants and bloodstream filters that fractured. Instead of insisting on full studies of such products, the FDA has allowed…




Source link



More