New House Bill Aimed At Detecting Medical Device Risks

Law360, New York (May 11, 2012, 5:00 PM EDT) -- U.S. Rep. Lois Capps, D-Calif., has introduced a bill, made available on Thursday, to improve the government's identification and analysis of risks associated with medical devices on the market.

The bill, called the Sentinel Assurance for Effective Devices Act of 2012, would amend the Federal Food, Drug and Cosmetic Act to expand the postmarket risk identification and analysis system to include medical devices.

If it's passed, the U.S. Food and Drug Administration would use claims data, patient survey data and other data as part of its...
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