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FDA Issues Draft Guidances to Scale Back Regulation of Digital Health Software

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued two draft guidance documents that describe types of software functions that FDA will not regulate, including FDA’s long-awaited policy on clinical decision support software. FDA published these documents in response to the 21st Century Cures Act, in which Congress removed certain low risk digital health software from FDA’s jurisdiction. In addition, as part of its broader Digital Health Innovation Action Plan, FDA announced that it was adopting as final guidance a document developed by the International Medical Device Regulators Forum (“IMDRF”) on clinical evaluation of software as a medical device. FDA also announced a January 30, 2018, public workshop on the progress of the Software Precertification (“Pre-Cert”) Pilot Program. Continue

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