Digital Health Center of Excellence
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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.
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SPECIAL TOPICS IN MEDICAL DEVICES

Interactive Overview of Digital Health Policies

Clinical Decision Support Software Final Guidance

Augmented Reality and Virtual Reality in Medical Devices

Updated List of Artificial Intelligence/Machine Learning-Enabled Medical Device…

The Software Precertification (Pre-Cert) Pilot Program Report
