FDA Continues To Down-Classify Digital Health Apps With New Cardio App Rule

14 Feb 2022

US regulators have officially down-classified adjunctive predictive cardiovascular indicator software to class II as part of a trend to make it easier for sponsors to apply for premarket applications.

WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images) — • Source: Sarah Silbiger/Getty Images (Sarah Silbiger/Getty Images)

FDA Continues To Down-Classify Digital Health Apps With New Cardio App Rule

More from Regulation

More from Policy & Regulation