The FDA approval process for medical devices would be streamlined under bipartisan legislation introduced by U.S. Rep. Mimi Walters (R-CA) on Wednesday.
The Medical Product Review Harmonization Act would eliminate regulatory redundancies for low- or moderate-risk medical devices to streamline the review process and spur innovation.
“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,” Walters said. “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.”
The legislation would also allow the U.S. Food and Drug Administration to grant 510(k) clearance, the 90-day review process that determines whether a device has an equivalent, for some class II medical devices.
“This common sense reform is the type of change the American people deserve,” Walters said. “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.”
U.S. Rep. Ami Bera (D-CA), who introduced the bill with Walters, said Congress owes it to Americans to “take an honest look” at which regulations are helping patient safety and which ones are getting in the way of better, more affordable health care.