FDA Must Step Up Medical Device Scrutiny: GAO

Law360, New York (January 29, 2008, 12:00 AM EST) -- The Food and Drug Administration has not been inspecting the production of medical devices as regularly as it is required to, the Government Accountability Office said at a Tuesday hearing on Capitol Hill.

The FDA is required to examine the manufacture of certain domestic medical devices every two years. But the agency generally inspects high-risk devices, such as pacemakers and defibrillators, every two years and moderate-risk products, such as hearing aids, every five years, GAO reported.

Imports from abroad are not regulated by any time schedule....
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