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

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)

The US Food and Drug Administration has down-classified cardiovascular software used to analyze heart vitals. The move is the latest from the agency in down-classifying digital health software that could help more sponsors submit premarket applications and increase market competition.

The FDA published on 14 February a final order stating adjunctive predictive cardiovascular indicator software are now class II...

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