A U.S. Senate panel yesterday advanced a bill that would create a fast-track program at the FDA for breakthrough medical devices.
The Senate Health, Education, Labor & Pensions committee sent the bill, S. 1077 or “A bill to provide for expedited development of and priority review for breakthrough devices,” to the Senate floor.
The bill, introduced last year by Sen. Richard Burr (R-N.C.), is co-sponsored by Sens. Orrin Hatch (R-Utah), Michael Bennet (D-Colo.) and Joe Donnelly (D-Ind.).
“The Advancing Breakthrough Devices for Patients Act (S.1077) builds on initiatives already underway within FDA to help create an accelerated and more predictable pathway for breakthrough medical technologies – those that offer the best hope for patients with life-threatening or irreversibly debilitating diseases or conditions who have no or limited alternative treatment options. Today’s action shows that the HELP committee recognizes the vital importance of giving patients access to truly breakthrough medical treatments,” AdvaMed senior executive vice president J.C. Scott said in prepared remarks.
The committee also advanced 2 other FDA-related bills, S. 1767, the “Combination Product Regulatory Fairness Act of 2015,” and the S. 1101, the “Medical Electronic Data Technology Enhancement for Consumers’ Health Act.” Scott said the former would “provide needed clarity to the agency’s process for reviewing combination products – whether device/drug, device/biologic or drug/biologic – ensuring more timely and predictable reviews of these novel products and again improving patient access in the long run.”
The MEDTECH bill is aimed at codifying the regulations for medical devices that use software.
“Taken together, these 3 bills will help improve patient access to some of the latest medical advancements and foster a more efficient, predictable and transparent review process within FDA, all the while maintaining the agency’s strong standards for safety and effectiveness,” Scott said.