The Clinical Decision Support Coalition penned a 21-page letter Feb. 5 urging the FDA to rewrite its guidance on clinical decision support software to avoid "overregulation."
The CDS Coalition — which includes representation from clinical societies, healthcare payers, healthcare providers and software developers — wrote its letter in response to the Clinical and Patient Decision Support Software draft guidance the FDA released in December. The draft guidance attempts to clarify what types of CDS and PDS software the FDA defines as a "medical device" in need of agency oversight.
Under the FDA's draft guidance, software that allows a user to "independently review" the basis for its recommendations are excluded from FDA regulation, such as CDS that suggests clinicians order particular tests consistent with existing guidelines. The FDA writes, "for the software function to be excluded from the definition of device, the intended user should be able to reach the same recommendation on his or her own."
However, the CDS Coalition argued the draft guidance's language would result in overregulation, requiring FDA oversight for technologies not previously under the agency's supervision.
The group argues the criteria outlined under the draft guidance would "expand the scope of FDA regulation to include numerous CDS software products simply because they offer insights," in turn regulating "any software that does not simply do mundane calculations that users could do themselves," according to a copy of the group's letter obtained by Becker's Hospital Review.
The CDS Coalition contends the FDA should implement a risk-based approach to its CDS oversight, stratifying software based on factors like the nature of a patient's disease and the role of the software in patient care. This system would enable the FDA to exempt "low-risk software" — for example, a tool that "guides a physician on how to treat an occasional headache," according to the CDS Coalition — from agency oversight.
"If implemented, the draft guidance would substantially expand the scope of FDA regulation and force many sellers of existing CDS software to remove their products from the market," the letter reads. "The resulting overregulation would be to the detriment of patient care."