Senators Push Breakthrough Pathway For Devices Bill That Mirrors 'Cures' Draft Language

Sens. Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced bipartisan legislation Thursday (April 23) that would create a breakthrough designation pathway for expedited FDA approval of medical devices -- a plan closely mirroring language in the House Energy and Commerce Committee's 21st Century Cures draft bill released in January. The Senate bill, hailed by the device industry, comes as FDA pushes a less-aggressive expedited approval plan that leaves out 510(k) devices, and as consumer advocates, Democratic senators...