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FDA and Digital Health Regulation

Health Blawg

The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA. Examples of things that will still be considered medical devices include: software programs that are intended to process or analyze medical images.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA. Examples of things that will still be considered medical devices include: software programs that are intended to process or analyze medical images.

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article thumbnail

FDA and Digital Health Regulation

Health Blawg

The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA. Examples of things that will still be considered medical devices include: software programs that are intended to process or analyze medical images.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA. Examples of things that will still be considered medical devices include: software programs that are intended to process or analyze medical images.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The draft CDS and PDS Guidance is intended to clarify what sorts of digital health tools will not be considered devices and thus not regulated by the FDA. Examples of things that will still be considered medical devices include: software programs that are intended to process or analyze medical images.