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Medical-device reviews scrutinized

Associated Press / September 24, 2009

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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, which has been criticized by safety advocates and government watchdogs.

The nonprofit Institute of Medicine will conduct a two-year review of FDA’s so-called 510k review procedure, which allows device companies to quickly launch products similar to those already on the market.

The announcement yesterday garnered approval from lawmakers.

“I have long been concerned that the 510k process permits too many devices on the market about whose safety and effectiveness even the FDA is uncertain,’’ said Representative Henry Waxman. “The result is hundreds of recalls of important devices for serious safety concerns.’’

The California Democrat chairs the House Energy and Commerce Committee, which oversees the FDA.

The 510k procedure was originally 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, Congress’s investigative arm, recently identified two dozen device types that were approved without close scrutiny, including hip replacements and heart implants.