Regulating Mobile Medical Apps
CDRH director Jeffrey Shuren says the agency has led a working group of regulators from several countries under the auspices of the International Medical Device Regulators Forum (IMDRF) to establish basic policies for a new, pragmatic, and internationally harmonized regulatory framework for software as a medical device (SaMD) that better meets patients’ and clinicians’ needs, and the rapid innovation cycles and business models of SaMD developers. Shuren describes the effort as part of FDA’s overall approach to regulating mobile medical apps in an opinion column in the Journal of the American Medical Association.
He notes that efficient regulation “can help promote adoption of mobile medical apps. FDA determination that a product developer or manufacturer has met the high regulatory standard for demonstrating clinical benefit and safety (when agency clearance or approval of the app is required) can increase consumer confidence in the technology. In these cases, FDA regulation also can help patients, payors, and investors better understand the performance characteristics of high-quality software products, encouraging a ‘race to the top’ in medical app development.”
The column lists benefits for mobile medical apps and discusses the regulatory framework enacted by Congress in 1976 and the reasons it is not well suited for software-based technologies.
“The traditional application of FDA’s longstanding regulatory framework can stifle the development of and access to new and improved SaMD while providing limited patient safeguards,” he writes. “To meet its core mission of promoting and protecting public health, it is important for FDA to create a regulatory framework for SaMD that recognizes the distinctive aspects of digital health technology, including its clinical promise, unique user interface, and compressed commercial cycles for new product introductions and modifications.”
He says that in 2011, FDA began issuing a series of policy guidances to provide market clarity as well as to deregulate many lower-risk functionalities for which active FDA oversight would provide little to no public health value while unnecessarily delaying patient access to potentially beneficial technologies.
In 2016, he says, the 21st Century Cures Act codified many of the agency’s new policies and added certain clinical decision support functionalities as no longer being medical devices subject to FDA oversight.
A 7/2017 Digital Health Innovation Action Plan described actions FDA committed to take to fully implement the software provisions of the Cures Act, including to issue new policy on clinical and patient decision support software, establish a dedicated Digital Health Unit in CDRH supported by industry user fee funding, and implement a new regulatory model for digital health technologies consistent with the IMDRF policies.