Digital Health Center of Excellence
Image
![Digital Health Center of Excellence Feature Graphic](https://public4.pagefreezer.com:443/content/FDA/01-06-2022T08:33/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
![GMLP Feature Graphic](https://public4.pagefreezer.com:443/content/FDA/01-06-2022T08:33/https://www.fda.gov/files/styles/medium_3/public/GMLP%20report%20feature.jpg?itok=7tj2X4Tp)
Good Machine Learning Practice for Medical Device Development: Guiding Principl…
![laptop with hands - feature for AI MI Enabled Medical Devices](https://public4.pagefreezer.com:443/content/FDA/01-06-2022T08:33/https://www.fda.gov/files/styles/medium_3/public/AIML%20drupal%20and%20email.jpg?itok=owovriZ2)
List of Artificial Intelligence/Machine Learning -Enabled Medical Devices
![Digital rendering of lungs superimposed over an image of two surgeons looking at a screen.](https://public4.pagefreezer.com:443/content/FDA/01-06-2022T08:33/https://www.fda.gov/files/styles/medium_3/public/AIML%20feature%20graphic.jpg?itok=bw1b5iOj)
Artificial Intelligence/Machine Learning (AI/ML)-Based Software Action Plan
![FDA Draft Guidance Webinar](https://public4.pagefreezer.com:443/content/FDA/01-06-2022T08:33/https://www.fda.gov/files/styles/medium_3/public/draft-guidance-webinar.jpg?itok=2wCQuyef)