FDA’s Digital Health Center of Excellence initiatives & guidance support growth in SaMD, mobile health devices, wearables

Its new acting director offers a status report on efforts to ensure safety of emerging medical device technologies, and what else lies ahead.

The Food and Drug Administration’s Digital Health Center of Excellence has completed several projects in its ongoing effort to ensure the safety of certain emerging medical device technologies, says Brendan O’Leary, who was recently named its acting director.

“DHCoE is not only a center of excellence, but also a new and important effort that will have an impact on patients,” O’Leary tells Health Data Management. 

Digital health technologies, as defined by the FDA, include Software as a Medical Device (SaMD), mobile health devices, wearables that are used as medical devices, and technologies used to study medical products. As the use of these technologies has grown in recent years, some patients and others have expressed concern about their safety, accuracy and reliability. 

DHCoE initiatives

O’Leary says the Center’s activities in the last few months have included:

  • Releasing draft guidance on the use of digital health technologies for remote data acquisition in clinical investigations and providing recommendations on collecting and transmitting the data.
  • Holding a workshop on the transparency of AI/ML learning devices and publishing a list of AI/ML-enabled devices marketed in the United States.
  • Issuing draft guidance on the content of premarket submissions regarding device software functions for FDA evaluation of the devices’ safety and effectiveness.
  • Collaborating with counterparts in Canada and the United Kingdom to create guidance principles for good ML practices for medical device development.

The center also is working on an artificial intelligence/machine learning action plan, including guidance on how to address AI/ML as it evolves, he adds.

Advancing health equity is another one of DHCoE’s priorities, the acting director says, noting that digital health “has a key role to play” in reducing health disparities.

Meanwhile, DHCoE is continuing its work on creating a software precertification pilot program that would serve as a first step toward creating a regulatory model to provide more streamlined and efficient oversight of software-based medical devices and help ensure their safety, O’Leary says.

DHCoE is in the process of concluding the pilot and will be issuing a final report soon. O’Leary notes however, fully implementing the program based on the concepts explored in the pilot will require legislation.  During the pilot, the FDA continued to make regulatory decisions under its existing authorities and processes. But it’s a challenge applying the existing regulatory framework to novel technologies, such as artificial intelligence/machine learning modifications, which change so quickly.

DHCoE’s ongoing role

The FDA created the DHCoE within its Center for Devices and Radiological Health in September 2020 to provide a centralized, comprehensive approach to digital health technology. It serves as a resource for developers, providers, patients, FDA staff and other stakeholders to modernize digital health policies and regulatory approaches, promote best practices and accelerate access to safe and effective digital health technology. The DHCoE keeps FDA staff apprised of digital health issues, responds to queries from the public, and works with a variety of entities in research and development. It will help set digital health research priorities for the Center for Devices and Radiological Health and develop a knowledge hub of tools and information for policy development and implementation. In its start-up phases, the DHCoE conducted listening sessions, developed resources, created a network of experts and built strategic partnerships for policy and regulatory science. About DHCoE, O'Leary says, “We’re a very collaborative group. We want to contribute to advance this field.”

Keeping up with innovation

DHCoE faces the challenge of dealing with technology that’s constantly evolving and a regulatory framework that cannot keep up with those changes, according to O’Leary, and adding that the Center can play an important role in improving regulatory efficiency, enhancing coordination within the FDA and externally, and providing scientific support in emerging areas, such as augmented and virtual reality products. “There’s a tremendous amount of innovation across the board that has great value and impact,” O’Leary says about digital health technology. "DHCoE will help the FDA focus on ensuring new devices are safe so that consumers can have confidence in them."

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