FDA and Digital Health Regulation
Health Blawg
DECEMBER 26, 2017
It is worth noting that the SaMD efforts are based on the principles articulated by a group of medical device regulators from around the world (IMDRF) which chartered a working group to look at SaMD; the IMDRF document was unanimously approved by its management committee and was adopted by the FDA. The Harlow Group LLC.
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