The CEO of the Advanced Medical Technology Association urged senators to approve the updated user fee agreement with the FDA that will allow manufacturers to develop innovative devices and digital health products.
During a Senate hearing examining updated FDA user fee agreements, Scott Whitaker, president and CEO of AdvaMed, said the fourth iteration of the Medical Device User Fee Agreement (MDUFA IV) continues the FDA’s previous work to facilitate innovation. In written testimony (PDF), Whitaker noted that failure to enact the agreement into law would “have a devastating impact on our industry’s ability to bring innovative diagnostics, treatments and cures to patients.”
“This agreement is good for industry. It is good for FDA. And most of all, it is good for patients,” he said.
President Trump's budget blueprint includes a proposal to increase user fees for drug and device companies in exchange for a streamlined approval process.
Whitaker added that MDUFA IV would decrease the time it takes for 510(K) and premarket approval and support the National Evaluation System for Health Technologies (NEST), which would integrate real-world evidence into the approval process.
Last week, Jeffery Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) told members of the House Energy and Commerce Subcommittee on Health that NEST would serve as a critical initiative that would rely on existing data buried in EHRs and health registries. Using real-world data could potentially save digital health and device companies millions of dollars typically spent on clinical trials.
Today, senators will question FDA nominee Scott Gottlieb during a confirmation hearing. Digital health experts have said Gottlieb could reshape the FDA’s approach to digital health, particularly in the way he interprets provisions of the 21st Century Cures Act.