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.
O’Leary’s comments come one day after the FDA issued its final report on a five-year Digital Health Software Precertification Program Pilot, or Pre-Cert, that tested more efficient regulatory processes for developers of digital health products. High-profile companies admitted to the program included Apple, Fitbit, Johnson & Johnson, Samsung, Verily, and Pear Therapeutics.
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