The U.S. Senate’s Health, Education, Labor & Pensions Committee this week floated an updated “manager’s amendment” to the House bill reauthorizing the user fee deal between the FDA and the medical device and drug industries.
The HELP panel’s amendments, issued ahead of a committee vote slated for tomorrow, include all of the elements hammered out in 2-year negotiations to date. It also includes a trio of new sections covering device facility inspections and regulatory improvements, pediatric devices and drugs and clinical trial requirements, according to Regulatory Affairs.
The Senate bill incorporates elements from House bills on over-the-counter hearing aids, improving domestic and foreign medical device inspections and harmonizing U.S. regulatory requirements with other overseas jurisdictions. The bill also has provisions covering device accessory classification and would allow the FDA to approve an imaging device with contrast agent for new indications.
The new pediatric language would give the Center for Devices & Radiological Health a year to help get medical devices for children to market. It would also require the FDA to issue guidance on pediatric oncology drugs.
The Senate version would also mandate that the U.S. Comptroller General issue a report by September 2018 on the federal safety watchdog’s progress on “(1) working with other regulatory authorities of similar standing to foster and encourage uniform, scientifically driven clinical trial standards with respect to medical products around the world; (2) providing consistent parallel scientific advice to manufacturers seeking simultaneous global development and approval of new medical products, in coordination with regulatory authorities of similar standing; and (3) facilitating the use of foreign clinical trial data to minimize duplicative clinical trials,” the website reported.