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FDA and Digital Health Regulation

Health Blawg

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.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

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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article thumbnail

FDA and Digital Health Regulation

Health Blawg

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.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

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.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

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.