Digital Health Center of Excellence Updates from CDRH

With much anticipation, I am pleased the FDA will host the inaugural Digital Health Advisory Committee meeting on November 20-21, 2024, in Gaithersburg, Maryland, and virtually. Please join us for this public meeting.  

The advisory committee will discuss—

• total product lifecycle considerations for generative artificial intelligence (AI)-enabled medical devices;
• how the use of generative AI-may impact safety and effectiveness of medical devices enabled with this technology; and
• premarket performance evaluation, risk management, and postmarket performance monitoring for generative AI-enabled devices.

Opportunities to participate in this meeting include contributing written comments through the public docket before November 1, 2024, or by providing an open public comment during the meeting.

Troy Tazbaz, Director, Digital Health Center of Excellence (DHCoE), Center for Devices and Radiological Health, U.S. Food and Drug Administration

Visit the advisory committee webpage for more information about the meeting.  

The FDA established a docket for public comment on the inaugural Digital Health Advisory Committee meeting to be held November 20-21, 2024, in Gaithersburg, Maryland. Interested persons may present data, information, or views orally or in writing, on issues pending before the advisory committee. Comments received on or before November 1, 2024, will be provided to the advisory committee. For more information about submitting comments, please see the Federal Register Notice. The docket will close on January 21, 2025.

The FDA published a digital health and artificial intelligence glossary as an educational resource to help support consistent use of digital health and artificial intelligence terminology by the FDA and interested parties (such as industry, digital health developers, academia, health care professionals, and patients). The FDA plans to update the glossary as needed.

On September 6, 2024, the FDA updated the list of medical devices that incorporate augmented reality (AR) and virtual reality (VR). With this update, the FDA has authorized 69 medical devices that incorporate AR/VR. View the list.

On August 7, 2024, the FDA updated the list of artificial intelligence and machine learning (AI/ML)-enabled medical devices. With this update, the FDA has authorized 950 AI/ML-enabled medical devices. View the list.

Have you used the Digital Health Policy Navigator? The FDA released this user-friendly tool to help developers determine whether their product's software functions are potentially the focus of the FDA's regulatory oversight. The Navigator walks you through seven steps, each with a set of questions to answer for each of your product's software functions. Your answers to these questions will help guide you through the most relevant FDA medical device regulatory considerations.

The Digital Health Center of Excellence is continuing to build a dynamic team that is at the forefront of advancing medical science, creating new opportunities, and providing a regulatory environment that brings safe and effective digital health technologies to market.

We are seeking candidates for multiple positions with a variety of experiences in AI, generative AI, and data science to serve as digital health specialists. Our innovative thinking and patient-centric digital health specialists assist CDRH and the FDA in developing new and enhancing existing strategies and regulatory policies focused on digital health technologies. Our digital health specialists develop and utilize methodologies and protocols to assess the quality, predictability, and performance of digital health technologies, such as medical devices with AI technologies, wearables, patient monitoring devices, and sensor-based digital health technologies.

The deadline for applications is November 20, 2024. For more information about the positions and to apply, visit:

• Digital Health Specialist – Generative AI
• Digital Health Specialist – Data Scientist