The US Food and Drug Administration (FDA) is currently developing a pilot program that considers the involvement of a third-party certification program, under which lower-risk digital health devices could be marketed without FDA pre-market review. The ‘Digital Health Innovation Plan’ introduced by the US FDA aims for a more efficient and risk-based approach to medical device regulation.
Earlier this month, the U.S Food and Drug Administration (FDA) released a statement on their attempt to regulate digital health devices by eliminating regulatory ambiguity, driving innovation, and freeing up regulators to focus on more important matters. The new Digital Health Innovation Plan focuses on advancing innovation at the intersection of medicine and digital health technology.
According to FDA Commissioner Scott Gottlieb’s blogpost, “Congress has already taken a major step to advance these goals in the 21st Century Cures Act. Expanding upon policies advanced by the FDA’s Center for Devices and Radiological Health (CDRH), the Act revised the FDA’s governing statute to, among other things, make clear that certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of FDA regulation. Such technologies tend to pose low risk to patients but can provide great value to the healthcare system. The FDA, led by CDRH, is working to implement the digital health provisions of the 21st Century Cures Act and, in the coming months, will be publishing guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies”.
The Digital Health Innovation Plan aims to create a more efficient and risk-based approach to the regulation of digital health devices. The FDA is currently developing a pilot program that considers the involvement of a third-party certification program, under which lower-risk digital health devices could be marketed without FDA pre-market review, while higher risk products could be marketed with a streamlined FDA pre-market review.
Gottlieb added, “the FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not. In addition, the FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that the FDA does not intend to subject them to certain pre-market regulatory requirements.”
This new plan will be the initial step to a broader effort that enables the FDA to offer an efficient regulatory approach for new low-risk digital health device technology in the healthcare industry. This will expedite the regulatory process in this field and facilitate the rapid innovation of promising, safe, and effective digital health devices.