On August 3, 2023, Inside Health Policy reported that the FDA has declined Center for U.S. Policy’s Citizen Petition urging the FDA to classify a risk assessment software as a misbranded medical device and mandate a recall to prevent potentially serious health consequences and fatalities. The FDA declined the petition, citing procedural grounds that prevent enforcement action based on a citizen petition. Nonetheless, the FDA has committed to evaluating the matter thoroughly to determine whether action is warranted.

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