The FDA's Center for Devices and Radiological Health is ramping up medical app and device offerings with a recently announced digital health unit.
The aim of this development is to centralize and coordinate digital health information so that there is consistency in applying policies. According to the associate director of digital health for the FDA, Bakul Patel, the primary responsibilities of those on the project will be to develop software and digital health tech to assist with premarket submissions or devices, utilize experts, and incorporate metrics that will aid review times and submissions.