FDA Eyes More Savvy Post-Approval Device Monitoring

Law360, New York (September 7, 2012, 5:58 PM EDT) -- The Food and Drug Administration on Thursday proposed ways to increase its postapproval monitoring of medical devices without having to go to Congress for more authority, focusing largely on using modern information technology to improve the beleaguered system.

The report stems from a 2011 recommendation by the Institute of Medicine, a nonprofit advisory organization, that the agency write a comprehensive strategy for postmarket surveillance, among other things, to improve its flawed device clearance process.

Under the current system, the FDA largely tracks problems, known as adverse...
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