The federal Food and Drug Administration has unveiled a plan to track high-risk medical devices.
A Wall Street Journal report on the policy says that it would require the high-risk devices to carry identification numbers. Jeffrey Shuren, director of the FDA’s medical-device center, described the plan as “a major game-changer” and said the agency plans to ramp up efforts to identify malfunctioning medical devices early.
For a long time, public safety advocates ...
continue reading...