The Food and Drug Administration’s approach to reviewing updates to software products is far slower than consumers have come to expect for apps, a top agency official acknowledged Tuesday.
Unlike many commonly used apps, which are frequently updated as developers fix bugs and add new features, updates to regulated digital health products often require a lengthy review. “Consumers really expect for their products to keep pace, and FDA’s modifications framework is really difficult with that,” said Brendan O’Leary, the acting director of the FDA’s Digital Health Center of Excellence, at the DTx East conference in Boston on Tuesday.
