Goto

Collaborating Authors

 bakul patel


FDA's Bakul Patel envisions a new regulatory approach to digital health

#artificialintelligence

As digital health innovation has outpaced the FDA's regulatory structure, the agency's top official wants to overhaul the approval process for new technology. That overhaul comes by way of a new Medical Device User Fee Agreement (MDUFA) that is making its way through Congress despite some recent pushback from Department of Health and Human Services Secretary Tom Price. A portion of the four-year agreement includes the creation of a central digital health unit within the FDA's Center for Devices and Radiological Health. RELATED: Tom Price revisits Trump's proposal to double FDA user fees Although that agreement wouldn't take effect until October, Bakul Patel, associate director for digital health, told Wired that he's already begun hiring key positions for the new department that will eventually include 13 engineers. Once he has a team in place, Patel wants to restructure the FDA's approach to digital health entirely, making it easier for new solutions and technology to get to market faster.