 
Digital Health Center of Excellence
January 9, 2024
Discover how the Digital Health Center of Excellence (DHCoE) at the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is leading the advancement of digital health to protect and promote public health.
Message from the DHCoE Director
As we begin 2024, I want to share with you an area of interest and an opportunity for digital health collaboration that touches the lives of so many people: diabetes. In today's modern age, we're seeing examples of new and innovative technologies ushering in advancements in patient care, and I believe that digital health technologies, including those enabled by Artificial Intelligence, hold immense promise in the effort to prevent, detect, reverse, and manage prediabetes and type 2 diabetes.
As part of this effort, we need your help. Please share your insights on how digital health technologies may help with early detection of risk factors for type 2 diabetes, prediabetes, and type 2 undiagnosed diabetes now through January 31, 2024.
To learn more about my thoughts on this initiative, please read my recent blog, “Digital Health Collaboration Fosters Innovation and Health Equity.”
This is our opportunity to make significant strides in advancing safe and effective digital health technologies and reducing the diabetes epidemic’s effect on individuals and society.
Troy Tazbaz
Director, Digital Health Center of Excellence
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DHCoE Activities
FDA Creates New Digital Health Advisory Committee
The FDA announced the creation of a new Digital Health Advisory Committee (DHAC) to help the agency explore the complex scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. Learn More about DHAC.
FDA Collaborates on Guiding Principles for Predetermined Change Control Plans in Artificial Intelligence and Machine Learning-Enabled Medical Devices
The FDA, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles. The five guiding principles outline key characteristics of robust Predetermine Change Control Plans. View the Guiding Principles.
FDA Adds 171 Devices to the List of Artificial Intelligence (AI) and Machine Learning (ML) Enabled Medical Devices
With this update, the FDA also added insights about trends based on analyses of the data. This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information. The FDA maintains this list to increase transparency about AI/ML-enabled devices in this rapidly progressing field. View the List.
FDA Releases New Augmented Reality (AR) and Virtual Reality (VR) Resources for Patients and Health Care Professionals
If you’re a patient, caregiver, or health care professional considering using AR/VR in your health care or practice, the FDA developed these infographics to help you weigh some of the benefits and risks and make an informed decision before using AR or VR medical devices.
Medical Extended Reality (XR), including AR/VR, may help advance health equity by providing care outside of traditional health care settings, such as at home or other non-clinical setting, or when a specialist is not locally available. View the Infographics.
FDA Creates Resource to Help Digital Health Developers with Answers to Common Questions
Are you developing a digital health product and have questions about medical device regulation? We created a list of frequently asked questions (FAQs) to help answer common questions about bringing safe and effective digital health technologies to market. The FAQs are intended to help you find resources quickly and suggest similar content that may interest you. View the FAQs.
We Are Hiring!
We are continuing to build a dynamic team that 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 applying to one of the following open positions, submit an electronic resume or curriculum vitae, cover letter containing a brief summary of accomplishments, SF-50 (if applicable), and a copy of unofficial transcripts all in one document (Adobe PDF) to DigitalHealth@fda.hhs.gov.
Open Positions
Digital Health Advisor
Seeking experts responsible for drafting, implementing, supporting, and furthering practices and policies that foster high-quality digital health technologies throughout the total product lifecycle. Candidates with modern software development and delivery experience designing technology solutions and high-quality software and hardware platforms for health care and medical devices industries with specialties in areas such as Extended Reality (XR), medical device interoperability, or In Vitro Diagnostics (IVD), to name a few, are encouraged to apply. Read the job description.
Contact CDRH’s Digital Health Center of Excellence
We help our stakeholders navigate the FDA's current policies on digital health products and provide informal feedback on the possible regulatory status of products in development. Please reach out to us with your questions!
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For questions about digital health regulatory policies, visit our website for helpful information and more on how to contact us.
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For general DHCoE questions, please email DigitalHealth@fda.hhs.gov.
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