The Latest FDA Move To Limit Digital Health Software Regs

By Gregory Levine, Abram Barth, Rebecca Williams and Sara Bodnar (December 21, 2017, 2:52 PM EST) -- On Dec. 8, 2017, the U.S. Food and Drug Administration issued two draft guidance documents that describe types of software functions that the FDA will not regulate, including the FDA's long-awaited policy on clinical decision support software. The FDA published these documents in response to the 21st Century Cures Act, in which Congress removed certain low-risk digital health software from the FDA's jurisdiction. In addition, as part of its broader Digital Health Innovation Action Plan, the 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. The FDA also announced a Jan. 30, 2018, public workshop on the progress of the Software Precertification (Pre-Cert) Pilot Program....

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