Institute of Medicine will review FDA’s system for clearing low-risk medical devices

FDA medical device approvals get external review

WASHINGTON — The Food and Drug Administration is asking the government’s top medical advisers to review its system for approving certain types of medical devices that has been criticized by safety advocates and government watchdogs.

The Institute of Medicine will study FDA’s so-called 510k review procedure, which allows device companies to immediately launch products similar to those already on the market.

The procedure was intended to speed the approval of simple devices like bandages and wheelchairs, but in recent years it has been used to approve high-risk devices.

The Government Accountability Office recently identified two-dozen device types that were approved without close scrutiny, including hip replacements and heart implants.