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.
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. One idea is to make the approval process more like a TSA security line, with trusted companies getting a lighter regulatory touch, while companies with a problematic history would undergo a more thorough vetting.
Either way, he wants to make sure federal regulations don’t get in the way of innovative products that are far different than devices the agency has overseen in the past.
“We’re headed toward a zero code world, where AI writes it for you or you just say what you want and natural language processing takes care of the rest,” Patel told Wired. “The pace will be tremendously faster than what we’re seeing today. The question is, how do we align our regulations to that radically different development timeline?”
The FDA has already loosened its approach to digital health, releasing new guidance last summer that indicated general wellness apps and devices wouldn't face FDA scrutiny. Industry experts have said newly appointed FDA commissioner Scott Gottlieb could continue the same kind of hands-off regulatory approach.
But the FDA isn’t the only agency that digital health companies have run up against. In March, a settlement between three mHealth app developers and the New York Attorney General's Office raised concerns about inconsistent state-based enforcement. Additionally, the FTC has shown a willingness to step in to ensure companies are following their privacy and security policies.