- FDA brass is vowing to develop a regulatory framework for mobile medical apps that supports innovation and commercialization of digital tools while protecting patient health, top officials asserted in a JAMA viewpoint.
- Software-based health technologies such as mobile apps, often called software as a medical device (SaMD), are increasingly used by providers and their patients to promote wellness, diagnose and treat diseases and manage chronic conditions.
- In the viewpoint, FDA Commissioner Scott Gottlieb, Center for Devices and Radiological Health chief Jeffrey Shuren and Bakul Patel, associate director for digital health at CDRH, highlight the steps the agency has taken to support development of and access to mobile medical apps.
The FDA has consistently signaled a hands-off approach to low-risk wellness mobile apps, while regulating higher-risk SaMD in a way that acknowledges software's unique characteristics.
“Efficient regulation can help promote adoption of mobile medical apps,” the FDA officials wrote.
“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,” they said. “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.”
Last June, Gottlieb released a Digital Health Innovation Plan aimed at streamlining the path to market for digital health devices and clarifying the agency’s role in mobile apps. Key to the plan is a pilot program that would allow makers of low-risk software-based medical devices to self-certify their products and avoid the traditional premarket review process.
The agency released an updated working model of the pilot program last month and said it hopes to finalize the model by the end of the year. Nine companies including Apple, Fitbit and Johnson & Johnson were selected to participate in the pilot, which is expected to start next year.
In December, the agency issued guidance clarifying when it will regulate certain types of clinical and patient decision support software as medical devices. It also signaled plans to not regulate mobile apps intended only to maintain or encourage healthy living, such as Fitbit. And it finalized harmonized guidance on SaMD, developed with the International Device Regulators Forum.
The FDA laid out some of its digital health goals for 2018 in a strategic roadmap released in January. Among the highlights were building out the Pre-Cert pilot program and finding new ways to evaluate the analytic and clinical validity of laboratory-developed tests, such as third-party review or a similar firm-based certification.