FDA Denies Petition To Recall CDS Opioid Software As Misbranded Device

By Jessica Karins / August 3, 2023 at 12:48 PM
Updated Story FDA has denied a request that it recall risk assessment software used for treating opioid misuse as a “misbranded” medical device, saying enforcement action cannot be taken as a result of a citizen petition but that it will investigate the matter based on information provided by a group that says the platform perpetuates health inequity. The move comes as FDA is engaged in an effort to regulate more CDS platforms as medical devices. The nonprofit...

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