The FDA has announced that it will create a new unit responsible for overseeing digital health products. According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define “what clinical validation looks like for software,” and will consider creating new premarket approval or clearance procedures for digital health products.
As Patel stated in an interview with Wired, the new unit will aim to keep up with emerging technology that uses artificial intelligence and machine learning to diagnose and treat patients. Patel noted that this kind of technology creates new and difficult challenges for regulators, who must figure out how to ensure that patients remain safe while keeping up with the increasing complexity and tighter release schedules that these new kinds of software bring.
“We’ve been trying to translate the current regulation paradigm for digital . . . [b]ut what we have today and what we’re going to have tomorrow are not really translatable. We need to take the blinders off, start with a clean sheet of paper.” –Bakul Patel, Associate Center Director for Digital Health, FDA
Wired reports that Patel is working to develop new models for testing and approving digital health products. Patel told Wired that “the idea is to get safe products to market faster, by having people compete on excellence rather than compliance.” One way the FDA might do this is by providing faster review with lower scrutiny for manufacturers with a long track record of safety and compliance.
According to FierceHealthcare that the new digital health unit will be part of the FDA’s Center for Devices and Radiological Health. While the new unit won’t be officially open until October, hiring of key staff is underway. Wired notes that the unit will be funded by the Medical Device User Fee program.