A new Senate bill introduced yesterday would create a fast-track program at the FDA for breakthrough medical devices.
The bill, S. 1077 or ” A bill to provide for expedited development of and priority review for breakthrough devices,” was sponsored by Sen. Richard Burr (R-N.C.) and co-sponsored by Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.).
The measure was assigned to the Senate Health, Education, Labor & Pensions Committee.
“While FDA has made great strides in recent years to improve the efficiency and predictability of the medical technology review process, more can be done to ensure that the most cutting-edge innovations – those that have the potential to provide the greatest patient benefit – are made available to patients and physicians, something the agency acknowledges as well,” Stephen Ubl, president & CEO of the Advanced Medical Technology Assn., said in prepared remarks.