Digital health is driving a revolution in health care and the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is setting the stage for these advances. As an important step in promoting the advancement of digital health technology, CDRH established the Digital Health Center of Excellence (DHCoE) in 2020.

The Digital Health Center of Excellence recent milestones include:

• Engaging with patients to discuss their views on augmented reality/virtual reality in health care;
• Updating the FDA’s list of artificial intelligence/machine learning-enabled medical devices (which now includes more than 500 authorized devices); and
• Completing FDA’s Software Precertification Pilot and sharing key findings from the pilot in a final report.

As year-end approaches, the Digital Health Center of Excellence looks ahead to continue setting the stage for the advancement of digital health to help protect and promote public health.

Launched a Tool to Help Stakeholders Navigate Digital Health Policies

On September 27, 2022, the FDA launched the Digital Health Policy Navigator to help stakeholders with navigating the FDA’s digital health policies. This tool guides users through a series of questions based on published digital health policies, to provide general information to help a user assess whether a particular software function meets the device definition and, if so, whether it is the focus of FDA’s oversight as a device. The tool directs users to the appropriate policies to learn more. View the Digital Health Policy Navigator.

Issued the Final Guidance: Clinical Decision Support Software

On September 28, 2022, the FDA issued the final guidance on Clinical Decision Support Software. The final guidance clarifies the scope of the FDA’s oversight of clinical decision support (CDS) software intended for health care professionals as devices. This guidance further clarifies that the FDA’s existing digital health policies continue to apply to software functions that meet the definition of a medical device, including software that provides decision support and is used by patients or caregivers. Read the Final Guidance.

The FDA has also developed a graphic to provide a visual overview of certain policies described in the guidance and examples of non-device CDS functions and device software functions for illustrative purposes. View the graphic.

The FDA hosted a webinar for industry, health care providers, and others interested in learning more about the final guidance. View Webinar Details.

Held a Patient Engagement Advisory Committee Meeting on Augmented Reality and Virtual Reality (AR/VR)

On July 12-13, 2022, the Patient Engagement Advisory Committee met to discuss and make recommendations on Augmented Reality (AR) and Virtual Reality (VR) Medical Devices, and factors to consider when evaluating AR/VR devices. Thought-provoking discussion highlighted challenging areas for patients and health care providers around this technology, including insights into challenges related to AR/VR use among vulnerable populations.

Watch Day 1 Presentations. Read Day 1 Transcript.

Watch Day 2 Presentations. Read Day 2 Transcript.

View Meeting Documents.

Authorized More than 500 Artificial Intelligence / Machine Learning-Enabled Medical Devices Marketed to Date in the United States

On October 5, 2022, CDRH’s Digital Health Center of Excellence updated the Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices on FDA.gov to add 178 devices to the list of AI/ML-enabled devices, legally marketed in the U.S. by 510(k) clearance, granted De Novo request, or approved PMA. With this update, the FDA has authorized 521 AI/ML-enabled medical devices. View the Updated List.

Completed the Software Precertification Pilot Program and Issued a Final Report

On September 26, 2022, the FDA issued the report, The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, marking the conclusion of the Pre-Cert Pilot Program and an important first step towards identifying regulatory approaches to software that can better promote and protect public health.

The report describes key findings from the pilot: the FDA has found that rapidly evolving technologies in the modern medical device landscape could benefit from a new regulatory paradigm, which would require a legislative change. The report also includes two appendices that dive deeper into the types of objectives a new approach could better support and the types of data, or key performance indicators (KPIs), that may provide insight into those outcomes. Read the Report.

Digital Medicine Society (DiMe) Launched Resources to Make Better Decisions, Faster, in Healthcare and Research

On July 18, 2022, DiMe released four Sensor Data Integrations Toolkits that address data architecture, data standards, implementation, and organizational readiness. These toolkits were created for key stakeholders, to advance their use of sensor data to make better decisions, faster, in healthcare and research.

Each toolkit was created for key stakeholders to help:

• Data producers generate high-quality sensor data;
• Data processors create value from sensor-generated data so it can be accessed and used successfully; and
• Data consumers capture value from sensor-generated data so that, with the appropriate permissions, it is readily accessible.

The Digital Medicine Society (DiMe) brings together different stakeholders including patients, industry, academia, and government agencies including CDRH’s Digital Health Center of Excellence.

View the Sensor Data Integrations Resources.

Released “Spotlight: Digital Health Regulatory Science Opportunities”

On October 27, 2022, CDRH’s Digital Health Center of Excellence published a Spotlight highlighting some areas of importance expressed by stakeholders internal to and external to the FDA. The Spotlight presents these current regulatory science areas of interest in digital health for all to consider.

The FDA also published a new webpage highlighting how, through digital health collaborations, the Digital Health Center of Excellence is fostering regulatory science research and partnerships. View the webpage and read the Spotlight.

We are continuing to build a dynamic team who is at the forefront of advancing medical science, creating new opportunities, and creating a regulatory environment that brings safe and effective digital health technologies to market.

If you are interested in joining our Digital Health team and learning about our Center, please visit the CDRH Jobs Page. To apply to our DHCoE Fellowship opportunities, please submit your resume and/ or CV to DigitalHealth@fda.hhs.gov.