Digital Health Center of Excellence
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![Digital Health Center of Excellence Feature Graphic](https://public4.pagefreezer.com:443/content/FDA/28-07-2023T13:45/https://www.fda.gov/files/styles/main_image_medium/public/dhcoe%20page%20image.jpg?itok=DJM3rUZL)
Our goal: Empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.
Our objectives: The Digital Health Center of Excellence aims to:
- Connect and build partnerships to accelerate digital health advancements.
- Share knowledge to increase awareness and understanding, drive synergy, and advance best practices.
- Innovate regulatory approaches to provide efficient and least burdensome oversight while meeting the FDA standards for safe and effective products.
Anticipated outcomes: Through fulfilling these objectives, we anticipate the following advancements across digital health:
- Strategically advance science and evidence for digital health technologies that meets the needs of stakeholders.
- Efficient access to a highly specialized expertise, knowledge, and tools to accelerate access to digital health technology.
- Aligned regulatory approach to harmonize international regulatory expectations and industry standards.
- Increased awareness and understanding of digital health trends.
- Consistent application of digital health technology policy and oversight approaches.
- Reimagined medical device regulatory paradigm tailored for digital health technologies.
Sub-Topic Paragraphs
SPECIAL TOPICS IN MEDICAL DEVICES
![Final Guidance Graphic](https://public4.pagefreezer.com:443/content/FDA/28-07-2023T13:45/https://www.fda.gov/files/styles/medium_3/public/Final-Guidance-CDRH.jpg?itok=XZy-TR8v)
Content of Premarket Submissions for Device Software Functions
![The Veterans Cardiac Health and AI Model Predictions (V-CHAMPs) Challenge, May 25-August 2, 2023](https://public4.pagefreezer.com:443/content/FDA/28-07-2023T13:45/https://www.fda.gov/files/styles/medium_3/public/Vchamps_updated%20date_drupal-01.png?itok=he6sE7oF)
V-CHAMPs Challenge Extended through August 2, 2023
![CFSAN Draft Guidance for Industry](https://public4.pagefreezer.com:443/content/FDA/28-07-2023T13:45/https://www.fda.gov/files/styles/medium_3/public/Guidance-Draft-2022-1600x900.png?itok=Km333qld)
Predetermined Change Control Plans for AI/ML-Enabled Devices
![Digital Health Policy Navigator](https://public4.pagefreezer.com:443/content/FDA/28-07-2023T13:45/https://www.fda.gov/files/styles/medium_3/public/Policy%20Navigator%20drupal_final-01.png?itok=pH0N8gO5)
Interactive Overview of Digital Health Policies
![laptop with hands - feature for AI MI Enabled Medical Devices](https://public4.pagefreezer.com:443/content/FDA/28-07-2023T13:45/https://www.fda.gov/files/styles/medium_3/public/AIML%20drupal%20and%20email.jpg?itok=owovriZ2)
Updated List of Artificial Intelligence/Machine Learning-Enabled Devices
![Digital Health Technologies (DHTs) for Drug Development](https://public4.pagefreezer.com:443/content/FDA/28-07-2023T13:45/https://www.fda.gov/files/styles/medium_3/public/DHCoE-DHTs.jpg?itok=MwmmD66s)