FDA Backs Off From Regulating Certain Types of Health Software

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.

One of the draft guidances, the 13-page “Clinical and Patient Decision Support Software,” outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medical device, and thus would not be regulated.

“For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation,” FDA Commissioner Scott Gottlieb, who testified before the Senate Committee on Health, Education, Labor & Pensions on Wednesday, said in a statement...

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