Lexology January 3, 2023
Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable assurance of safety and effectiveness under a regulatory framework for devices that dates back to 1976. Major changes impacting digital health companies came with the passage of the 21st Century Cures Act in 2016, which carved out certain categories of software from FDA oversight. Since then, the FDA has issued numerous guidance documents providing details on these carve outs, as well as the agency’s general approach to regulating digital health technologies.
In its early digital health guidance documents, the FDA sought to harmonize its thinking with that of the international community, but it also...
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