GAO Tells FDA To Toughen Class III Device Review

Law360, New York (January 15, 2009, 12:00 AM EST) -- A new report from the U.S. Government Accountability Office is recommending that the U.S. Food and Drug Administration ratchet up its review process for medical devices that are designated class III, or “high risk,” in order to comply with legislation that is almost two decades old.

According to the report, which was published Thursday, Congress expected the FDA to require all class III devices to undergo a stringent premarket approval process pursuant to the Safe Medical Devices Act of 1990.

Since then, however, the agency has...
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