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In this document released on December 8, 2017, the U.S. Food and Drug Administration (FDA) proposes changes to previously published FDA guidance documents to be consistent with the Cures Act and reflective of the agency’s new, more modern approach to digital health products. It includes a change in definition of the software function intended for administrative support of a health care facility, the software function intended for maintaining or encouraging a healthy lifestyle, the software function intended to serve as electronic patient records, and the software function intended for transferring, storing, converting formats, displaying data and results . . .
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