CDS Coalition Provides Comments on FDA’s Reproposed “Clinical Decision Support Software: Draft Guidance for Industry and FDA Staff”
On December 13, 2019, the CDS Coalition submitted comments on FDA’s Reproposed “Clinical Decision Support Software: Draft Guidance for Industry and FDA Staff,” which was originally proposed on December 8, 2017.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 the CDS Coalition appreciates 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) exclude more software as low risk; (ii) 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; and (iii) not limit its enforcement discretion to only patient-directed software that informs clinical management for non-serious situations or conditions.