Digital Health Center of Excellence Updates from CDRH

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Digital Health Center of Excellence - Updates from CDRH

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“Under Bakul’s leadership, our digital health capabilities and services grew significantly. In his new role as Chief Digital Health Officer of Global Strategy and Innovation, Bakul’s contribution as a strategic thought leader will further support our vision for digital health and build upon years of progress. I encourage everyone to read our strategic priorities to better understand how we are taking bold steps to embrace innovation, address bias, and support a diverse, agile workforce—all critical for a well-functioning public health ecosystem.”

--Jeff Shuren, M.D., J.D.
Director, CDRH

February 4, 2022

Bakul Patel

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 excited about these advances. As an important step in promoting the advancement of digital health technology, CDRH established the Digital Health Center of Excellence (DHCoE) to empower Digital Health stakeholders by promoting awareness, transparency, and consistent application of digital health regulatory policies; pioneering the development and enhancement of digital health regulatory paradigms; and fostering digital health-focused collaborations.

The DHCoE was officially launched in September 2020 and we are pleased to update you on the work we did, in conjunction with our stakeholders, to strategically advance regulatory science and evidence for digital health technologies, and to foster responsible and high-quality digital health innovation.

In 2022, we will continue to grow and advance the work of the DHCoE. To help support this work and the implementation of the 2022-2025 CDRH Strategic Priorities, I am taking on a new role as the Chief Digital Health Officer of Global Strategy and Innovation. In this new role, I look forward to helping drive our global strategic vision of advancing health through technology innovation. While we work to select the next Director, the DHCoE will continue our work with stakeholders from across and beyond the FDA, both nationally and internationally, to fulfill our mission.

Please be on the lookout for continuing updates from us, here at the DHCoE!

-Bakul Patel, CDRH Chief Digital Health Officer of Global Strategy and Innovation

DHCoE Activities

Promoting awareness, transparency, and consistent application of digital health regulatory policies

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Released a List of Artificial Intelligence and Machine Learning (AI/ML) Devices

Over the past decade, the FDA has reviewed and authorized a growing number of medical devices legally marketed (through 510(k) clearance, granted De Novo request, or Premarket Approval) with machine learning across many different fields of medicine—and expects this trend to continue.

On September 21, 2021, the DHCoE developed this new list to increase transparency and access to information on AI/ML-based medical devices. View the list.

Laptop computer screen showing many windows with a presenter and workshop attendees, title is CDRH Virtual Public Workshop.

Held a Virtual Public Workshop on Transparency of AI/ML-enabled devices

On October 14, 2021, the DHCoE hosted a virtual public workshop on transparency of AI/ML-enabled medical devices for patients, caregivers, and providers. We discussed the role of transparency that enhances safe and effective use of AI/ML-enabled medical devices, with an emphasis on information sharing methods such as labeling. Watch the recording.

Graphic with the Food and Drug Administration logo and the words Draft Guidance Webinar

Released Two Digital Health-Related Draft Guidances

On November 3, 2021, the FDA released a draft guidance on the Content of Premarket Submissions for Device Software Functions. It is intended to provide information about the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions. Read the Draft Guidance. Watch the Webinar.

On December 22, 2021, the FDA released a draft guidance on Digital Health Technologies for Remote Data Acquisition, which intends to provide the clarity needed to encourage the exploration of these technological advances. Read the Draft Guidance. Register for the Webinar.

logos for the United States Food and Drug Administration, Health Canada, and the United Kingdom’s Medicine and Healthcare products Regulatory Agency.

Pioneering the development and enhancement of digital health regulatory paradigms

Collaborated on 10 Guiding Principles for Good Machine Learning Practice for Medical Device Development

On October 27, 2021, the FDA, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency jointly issued the Good Machine Learning Practice for Medical Device Development: Guiding Principles. These guiding principles will promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML). Read the Guiding Principles.

Blue cover page of report titled: Developing a Software Precertification Program: A Working Model.

Continued to Advance Development of the Software Precertification (Pre-Cert) Pilot Program

The Pre-Cert Pilot Program has helped to inform the ongoing development of a future regulatory model that can provide more streamlined and efficient regulatory oversight of software-based medical devices.

In 2021, the DHCoE initiated a partnership with a Federally Funded Research and Development Center (FFRDC), operated by the MITRE Corporation (MITRE), to provide professional engineering and technical support to help model an appraisal process— an approach to assess the ability of organizations to perform high-quality software design, testing, and monitoring, for software-based medical devices. Read More about Pre-Cert.

Fostering digital health-focused collaboration and coordination

Initiated Digital Health-Related Regulatory Science Research Projects  

In 2021, we progressed seven regulatory science research projects related to digital health technologies in the areas of artificial intelligence and machine learning, virtual reality and augmented reality, and real world performance

Medical Device Innovation Consortium Logo

Medical Device Innovation Consortium (MDIC) Launched a Digital Health Initiative

In September 2021, MDIC in collaboration with the FDA and other stakeholders, launched a digital health initiative. This is an opportunity to focus additional efforts in Software as a Medical Device, Software in a Medical Device, Mobile Medical Applications, Interoperability, Wireless Medical Devices, Patient-Generated Health Data, and In-silico validation/modeling. Learn more about the MDIC Digital Health Initiative.

Collaborative Community logo

Digital Health Measurement Collaborative Community (DATAcc) Announced Digital Inclusion Initiatives

In July 2021, DATAcc announced its first two projects, which will bring together stakeholders from across the healthcare industry to pre-competitively collaborate on the challenge of diversity, equity and inclusion in digital health measurement. Read more about the DATAcc digital inclusion initiatives.

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We Are Hiring!

In 2022, we are continuing to build a dynamic team who is at the forefront to advance medical science, create new opportunities, and create a regulatory environment that brings safe and effective digital health technology to market.

Open Positions

NEW Data Scientist Seeking an expert who will be responsible for planning, leading, and coordinating all data science related activities for the Digital Health Program. Read the job description.

Digital Health Advisor Seeking an expert who understands what it takes to develop, deliver, and maintain high quality digital health technologies during the FDA's review and evaluation of digital health technologies. Read the job description.

Contact the Digital Health Center of Excellence

Last year, the DHCoE responded to over 700 inquiries from external stakeholders, an increase of nearly 40% since 2018. We helped our stakeholders navigate the FDA's current policies on digital health products and provided informal feedback on the possible regulatory status of products in development. Please reach out to us with your questions!

  • For questions about digital health regulatory policies, visit our website for helpful information and more on how to contact us.
  • For general DHCoE questions email