FDA Issues Final ID Rule For Medical Devices

Law360, New York (September 20, 2013, 3:52 PM EDT) -- The U.S. Food and Drug Administration on Friday released its long-anticipated final rule for a unique device identification system that will require medical device manufacturers to label their products with codes to improve product recalls, neaten electronic health records and help deter device counterfeiting.

The proposal has caught some controversy, particularly a proposed rule that would have required implantable device manufacturers to directly mark the information on the devices instead of their packaging. But the final rule abandons that idea and instead requires product serial numbers,...
To view the full article, register now.