To better align the FDA with the rapidly changing digital health environment, last year the agency opened the Digital Health Center of Excellence (DHCoE).
The launch of the DHCoE further solidifies the agency’s dedication to the advancement of digital health technology, such as mobile health devices, SaMD, wearables that are used as medical devices, and technologies that are now commonly used to study medical products.
The DHCoE serves various stakeholders—including patients, developers, healthcare providers, researchers, industry, payors, other government agencies, international regulatory bodies, and other centers within the FDA—and is tasked with empowering these digital health stakeholders to advance health care by fostering responsible, high-quality digital health innovation.
Digital health tools and technologies fall under the FDA’s definition of devices, which
are instruments used in the “diagnosis, cure, mitigation, treatment, or prevention of disease, or that affect the structure or function of the body.” The FDA has the authority to regulate medical devices, including software that is considered a medical device.