Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “Stakeholders See More Holes in FDA’s Revised CDS Draft Guidance,” by Mark McCarty. (Read the full version – subscription is required.)

Following is an excerpt:

The FDA’s revised draft guidance for clinical decision support (CDS) systems was intended to fix several glaring holes in the first draft, but multiple stakeholders argued that the second draft contradicts the related provisions of the 21st Century Cures Act when it comes to CDS systems that purport to drive or guide clinical decision making. …

FAH says draft’s proposals require rulemaking

The Federation of American Hospitals (FAH) said in comments to the docket that it has “multiple concerns” with the draft. …

Writing on behalf of the Clinical Decision Support Coalition, regulatory attorney Brad Thompson of Epstein Becker Green, thanked the FDA for revising the initial draft so that it reflects a greater emphasis on risk. Thompson noted that the coalition’s comments to the initial draft recommended that the FDA adopt the IMDRF risk stratification framework, and to exempt low-risk offerings that do nothing more than inform clinical management.

Thompson said the IMDRF had spelled out the terms of three “inform clinical management” scenarios for CDS, but that the agency had adopted only the criterion of providing information to inform clinical management in a non-serious situation or condition. Left out from the IMDRF set of criteria was “driving clinical management” in a non-serious situation, as was information to inform clinical management in a serious situation.

Thompson said the draft’s terms exempt only one of the 22 products listed in the draft’s appendix, adding that the FDA should explain “in a data-driven manner,” why the draft sets out the limits thus characterized. He said the draft “advances the rather convoluted argument” that software that “drives” clinical management falls outside the statutory language that requires that software that makes recommendations is exempt from FDA regulation.

Doctor still in the loop

These products are not closed-loop systems, Thompson noted, reiterating the FAH position that software as a medical device “merely informs a human who then makes the decision.” He said the distinction between guiding and recommending “is a distinction without substance.”

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