CPC Provides Comments on FDA’s Reproposed “Clinical Decision Support Software: Draft Guidance for Industry and FDA Staff”

On December 20, 2019, the CPC submitted comments on FDA’s Reproposed “Clinical Decision Support Software: Draft Guidance for Industry and FDA Staff,” which was originally proposed on December 8, 2017. While we appreciate that this reproposed CDS guidance draft moves toward a risk-based approach, we believe it does not go far enough. In particular, the Agency should: (i) apply the same regulatory framework to software regardless of the legal manufacturer, (ii) exclude more software from regulation as low risk; (iii) not try to limit the scope of the Cures Act’s transparency exclusion to only software which, in the IMDRF terminology, merely informs or provides options regarding clinical management of patients; (iv) not limit its enforcement discretion to only patient-directed software that informs clinical management for non-serious situations or conditions; and (v) clarify, with more explicit discussion and specific examples, the level of software description needed to allow intended users to independently evaluate the basis for the software’s recommendation.