Third time’s a charm? FDA Issues Final Guidance on Regulation of Clinical Decision Support Software

October 2, 2022By Steven J. Gonzalez & Philip Won & Gail H. Javitt

On September 28, 2022, FDA published its long-awaited final guidance document entitled “Clinical Decision Support Software,” which interprets the medical software provisions of the 21st Century Cures Act (Cures Act). The final guidance was preceded by two iterations of draft guidance—one in 2017 and one in 2019—each of which garnered extensive public comment. We discussed the evolution of FDA’s CDS guidance, in previous blog posts here, here, and here.

The Cures Act excluded from FDA oversight certain software functions, including those that are intended to “support or provide recommendations to a healthcare professional (HCP) about prevention, diagnosis, or treatment of a disease or condition,” i.e., “clinical decision support” functions, subject to specified conditions. FDA’s draft guidance documents sought to establish criteria for three categories of CDS, those that: (i) did not meet the statutory device definition (Non-Device CDS); (ii) while technically devices, would be subject to enforcement discretion; and (iii) would be actively regulated (Device CDS).  In contrast, the final guidance focuses solely on Non-Device CDS. Consequently, the final guidance no longer articulates a policy of enforcement discretion for any CDS software, although the guidance notes that certain CDS software “may” fall under enforcement discretion policies found in FDA’s other guidance documents related to low risk software products. See Policy for Device Software Functions and Mobile Medical Applications; Software as a Medical Device (SaMD): Clinical Evaluation; Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; and General Wellness: Policy for Low Risk Devices (HPM has written about several of these policies and their past iterations here, here, here, and here).

The final guidance also seeks to shed light on a key statutory condition for exclusion from FDA regulation, namely, that the software enables a health care provider “to independently review the basis for” the software’s recommendations.  This prong of the statutory exemption has led to much uncertainty among stakeholders about the regulatory status of particular CDS software products. The final guidance makes recommendations about software and labeling that will provide the requisite independence, which are “based on FDA’s experience” evaluating CDS functions but acknowledges that “sponsors may use alternative approaches.”

There is much to unpack in the final guidance, and it will undoubtedly have significant implications for stakeholders in the burgeoning CDS software sector.  Stay tuned for an in-depth analysis on the blog in the coming week!

Categories: Medical Devices