Bill Would Mandate Postmarket Studies After 510(k) Approvals

December 21, 2011
A new Senate bill could force devicemakers to conduct more postmarket studies after 510(k) clearance, in a move being protested by industry groups. The Medical Device Patient Safety Act is being co-sponsored by Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.). The legislation would allow the FDA to make companies track implanted devices that were approved without human testing.
Devices & Diagnostics Letter