In September 2019, the Food & Drug Administration (FDA) issued a new draft “Clinical Decision Support Software” guidance for public comments, which are due December 26, 2019. Concurrently, the agency published updates to four related guidance documents centered on regulation of digital health software products along with a consolidated summary titled “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,” but is not soliciting comment on those. All of these guidance documents now account for the exclusion of certain software functions from the definition of “device” under the 21st Century Cures Act (Cures Act) amendments to the Food, Drug, and Cosmetic Act (FDCA) in 2016 and clarify FDA’s enforcement and monitoring positions vis-à-vis its legal authorities.
The rapid expansion of software and mobile medical applications in health care has made this guidance necessary in order to manage the FDA’s regulatory scope and provide clarity to medical device and health care companies seeking to use more software and mobile app solutions in their products and services. Digital health stakeholders, particularly medical device manufacturers, software developers, and mobile medical application developers should consider the effect of these guidance documents on their go-to-market strategies and submit comments regarding items from the FDA’s newest guidance documents that would create unnecessary burden or not address patient safety issues or other risks that FDA seeks to mitigate. We summarize the key points of each of the FDA’s guidance documents below.