U.S. FDA invites outside review of device approvals

U.S. FDA invites outside review of device approvals

The Institute of Medicine has decided to study a U. S. Food and Drug Administration program that gives fast-track approval to some medical devices.

The FDA has been criticized by lawmakers and consumer watchdog groups for speeding up the process of approving much more medical devices than the congress initially intended to.

Companies tend to get approvals for their products from the FDA by projecting their devices to be similar to the existing products and get them marketed quickly.

The study was needed by a 2007 law but the FDA has clarified that it may only be complete till March 2011.

Investigators from the Congress have reported previously that the FDA has allowed the marketing of products that are classified as high-risk through the expedited process.

They are of the opinion that complex medical devices such a heart valves and pacemakers should be reviewed thoroughly to establish their safety standards.

House of Representatives Energy and Commerce Committee Chairman Henry Waxman said, "I have long been concerned that the... process permits too many devices on the market about whose safety and effectiveness even the FDA is uncertain".

Announcement of the study has stirred up the agency's Center for Devices and Radiological Health since Dr. Margaret Hamburg took over the agency, who is President Barack Obama's choice for FDA Commissioner.

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