Coalition Challenges FDA’s Clinical Decision Software Guidance

A citizen petition filed on behalf of the Clinical Decision Support Coalition has called on the FDA to rescind its September 2022 final guidance on Clinical Decision Support Software (CDS).

The coalition — which includes “clinical decision support software developers that have been traditionally unregulated, IT infrastructure manufacturers, and regulated medical device manufacturers,” — claims that Congress did not intend for the agency to take up more regulatory authority on CDS and that the resources needed to regulate CDS are wasted as “there is no public health risk associated” with CDS products.

The coalition is urging the agency to draw “the correct jurisdictional line between regulated and unregulated software” and calling for clinical decision support software that “appropriately balances the need for regulatory oversight with the need for innovation and access to new technology.”

The 28-page petition asserts that the CDS guidance is at odds with other federal policies and congressional intent, and that the FDA is “harming, not helping, public health by dissuading innovators from evolving CDS software for the betterment of the public and imposing arbitrary rules on technology development that do not serve their intended purpose.”