The Food and Drug Administration (FDA) Dec. 7 released three guidance documents to improve the development and oversight of digital health tools, a continuation of steps the FDA has taken over the last five years to better align its regulatory approach with the evolving nature of digital health technologies. The guidance documents also make several important changes to meet requirements in the 21st Century Cures Act (“Cures Act”).
The first draft guidance, Clinical and Patient Decision Support Software, implements a risk-based approach to determining the types of clinical decision support software that would not be defined as a medical device and therefore would not require FDA regulation (e.g., programs comparing patient symptoms). Among other things, the guidance recommends that regulatory requirements should not be enforced for lower risk decision software such as patient decision support software, when that software is used independently by patients and non-health professions in the review of treatment recommendations.
The second draft guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, provides clarification of the FDA’s interpretation of certain software that are no longer medical devices and fall outside the scope of FDA’s regulation. Comments on both draft guidance documents are due by Feb. 6, 2018, 60 days from publication in the Federal Register.
Third, the FDA issued a final guidance document Software as a Medical Device: Clinical Evaluation, establishing common principles for evaluating the safety, effectiveness, and performance of software regulated as a medical device.
In a press release, Commissioner Scott Gottlieb, MD, emphasized the importance of the FDA’s role in the development of such technologies, stating that these guidance documents will “continue to expand our efforts to encourage innovation in the ever-changing field of digital health [and] provide more clarity on and innovative changes to our risk-based approach to digital health products so that innovators know where they stand relative to the FDA’s regulatory framework.”