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FDA Weighs When Software Becomes A Medical Device

Axios interviewed Of Counsel Benjamin Zegarelli  about the citizen petition that was filed with the FDA to recall Bamboo's NarxCare. Benjamin said, "The intrigue: An agency decision that NarxCare be considered a medical device could put the FDA in conflict with some state law. The FDA would have to decide whether it has a specific oversight over the software, or potentially say that NarxCare falls under state jurisdiction under the argument that it enables state-run PDMPs."