On December 7, 2017 the Food and Drug Administration (FDA) took their next step in the implementation of the 21st Century Cures law, with the release of three new policy documents in hopes of advancing the FDA’s approach to the development and proper oversight of innovative digital health tools. This release is another step in the agency’s Digital Health Innovation Action Plan, which began this past summer and outlines the FDA’s efforts to reimagine its approach to ensuring all Americans have timely access to high-quality, safe and effective digital health products. The three new guidances-two draft and one final-offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement.
The first draft guidance, “Clinical and Patient Decision Support Software,” outlines the FDA’s approach to clinical decision support software (CDS). This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making. The FDA wants to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies. This draft guidance is intended to make clear what types of CDS would no longer be defined as a medical device, and would not be regulated by the agency. For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation.
The second draft guidance being released, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,” addresses other digital health provisions included in the Cures Act. Specifically, this second guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices. The agency is making clear that certain digital health technologies – such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle – generally fall outside the scope of the FDA’s regulation. Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system. Both of these draft guidance are subject to stakeholder comments which are due on February 6, 2018.
Finally, the FDA also issued a final guidance, “Software as a Medical Device: Clinical Evaluation,” in fulfillment of international harmonization efforts. This guidance establishes common principles for regulators to use in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD). This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product.