Senate Bill Would Streamline FDA's New Device Reviews

Law360, New York (February 3, 2012, 3:27 PM EST) -- Two lawmakers on the U.S. Senate's top health committee introduced legislation Thursday that they said would dramatically shorten the U.S. Food and Drug Administration’s approval process for innovative medical devices.

Sens. Bob Casey, D-Pa., and John McCain, R-Ariz., said their bill would streamline the regulatory review process for brand-new medical devices that aren't similar to any existing devices.

Under the Safe, Efficient and Transparent Medical Device Approval Act, manufacturers with such new devices would be able to skip the 510(k) process, which the senators said was...
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