The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its overarching dedication to the advancement of digital health technology, including mobile medical devices, software as a Medical Device (SaMD), artificial intelligence (AI) and wearables when used as a medical device.
This is the latest in a series of efforts by the FDA over the past year – including issuing product guidance and refining its digital health pre-certification program – to enact policies and programs that will promote innovation while ensuring appropriate regulatory oversight of digital health products.
FDA regulates digital health products under the same general parameters as it does other medical devices. If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, it is regulated as a medical device. However, FDA has acknowledged and recognized that while digital health products may be medical devices, they are unique types of devices and constantly evolving. As such, FDA has created general regulatory categories for digital health products based on the product's intended use and risk level, as such, digital health products may: 1) fall outside the statutory definition of a medical device and therefore not be regulated by FDA, 2) meet the definition of a medical device but is low risk and falls within FDA's enforcement discretion and 3) meet the definition of a medical device and FDA's device regulations and rules apply. Note that these categories were developed prior to the COVID pandemic and apply to digital health products regardless of whether or not they have a COVID application.
The agency's announcement of the Digital Health Center of Excellence comes at a time when the market is being flooded with digital health products as medical apps, wearables and other products are becoming more prevalent. The goal of the Digital Health Center of Excellence is to coordinate and support work across the agency, advance best practices, be a clearinghouse of information and provide real-time digital health device regulatory oversight. FDA is committed to a "comprehensive approach to digital health technology to realize its full potential" and the Digital Health Center of Excellence "will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public and FDA staff."
While the precise activities of the center are still developing, FDA expects it to interact regularly with industry stakeholders, researchers and interested parties. As such, the agency will host listening sessions in the coming weeks for stakeholders to learn about the Digital Health Center of Excellence, and provide feedback about its proposed activities to ensure it is a valuable resource.
The digital health world is ever changing. If device manufacturers, developers, healthcare providers, researchers and other stakeholders have questions about FDA's regulatory applicability to its products, Holland & Knight has extensive experience in the space.