Digital Health Center of Excellence
Image
![Digital Health Center of Excellence Feature Graphic](https://public4.pagefreezer.com:443/content/FDA/04-10-2023T15:54/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
![Augmented Reality Virtual Reality Feature graphic](https://public4.pagefreezer.com:443/content/FDA/04-10-2023T15:54/https://www.fda.gov/files/styles/medium_3/public/Augmented_Reality-Virtural-Reality-Feature.jpg?itok=Wpm_dc54)
Questions to consider when using AR and VR Medical Devices
![Digital Health Frequently Asked Questions](https://public4.pagefreezer.com:443/content/FDA/04-10-2023T15:54/https://www.fda.gov/files/styles/medium_3/public/Digital%20Health%20Frequently%20Asked%20Questions.png?itok=PuxRaRmx)
Digital Health Frequently Asked Questions
![V-CHAMPs Challenge Feature](https://public4.pagefreezer.com:443/content/FDA/04-10-2023T15:54/https://www.fda.gov/files/styles/medium_3/public/Vchamps_date%20removed_drupal-01.png?itok=eaTWpbkT)
V-CHAMPS Challenge: Phase 1 Top Performers
![CFSAN Draft Guidance for Industry](https://public4.pagefreezer.com:443/content/FDA/04-10-2023T15:54/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/04-10-2023T15:54/https://www.fda.gov/files/styles/medium_3/public/Policy%20Navigator%20drupal_final-01.png?itok=pH0N8gO5)
Interactive Overview of Digital Health Policies
![Digital Health Technologies (DHTs) for Drug Development](https://public4.pagefreezer.com:443/content/FDA/04-10-2023T15:54/https://www.fda.gov/files/styles/medium_3/public/DHCoE-DHTs.jpg?itok=MwmmD66s)