For Immediate Release
May 17, 2017
Contact: T.W. Arrighi
Reps. Walters and Bera Introduce Bipartisan Bill to Streamline Medical Device Innovation
Washington, D.C. – Yesterday, Rep. Mimi Walters (R-CA45) and Rep. Ami Bera (D-CA07) introduced H.R. 2474, the Medical Product Review Harmonization Act of 2017, a bipartisan bill to streamline the approval process for medical devices.
The bill simplifies repetitive and burdensome regulations in the review process for certain low- to moderate-risk medical devices. These regulatory redundancies delay patient access to medical devices and leads to inefficient use of FDA resources. The bill will allow the FDA to grant 510(k) clearance for certain Class II medical devices that comply with objective, published criteria developed by FDA.
Regarding the legislation, Congresswoman Walters said, “The improvement of medical care is due in large part to the innovation of the instruments and devices that carry out the procedures that keep us healthy. Unfortunately, unnecessary regulations hinder progress on new advancements that could save and improve lives.
“That is why I introduced a bill aimed at promoting innovation and eliminating redundancies in the FDA’s regulations while maintaining standards to ensure safety and efficacy. This common sense reform is the type of change the American people deserve. I have no doubt that this legislation will spur advancements in the medical device industry, which will help lower health care costs and save lives.”
Congressman Bera said, “We owe it to Americans to take an honest look at what regulations are helping patient safety and which ones are getting in the way of better, more affordable health care. This bill helps us streamline some of these cumbersome processes to encourage innovation and ensure timely patient access to that innovation.”
Walters represents California’s 45th District and serves on the House Energy and Commerce Committee.