CDRH’s Digital Health Center of Excellence: Advancing Regulatory Science
The Center for Devices and Radiological Health (CDRH) is seeking public input on how digital health technologies, including those enabled by artificial intelligence and machine learning (AI/ML), can aid in the early detection of risk factors for type 2 diabetes, prediabetes, and undiagnosed type 2 diabetes. This initiative is part of CDRH’s broader mission to protect and promote public health through responsible digital health innovation.
Areas of Interest
CDRH’s Digital Health Center of Excellence (DHCoE) has identified key areas of regulatory science research in digital health. These areas include:
- Artificial Intelligence/Machine Learning (AI/ML)
- Digital Biomarkers
- Digital Health Technologies
- Real World Data and Performance
The DHCoE published a ‘Spotlight’ document on October 27, 2022, highlighting important research areas identified by internal and external stakeholders. This document serves as a guide for stakeholders to consider when developing digital health technologies.
Partnerships and Collaborations
CDRH’s DHCoE collaborates with various stakeholders, including patients, researchers, healthcare providers, medical product manufacturers, technology companies, and standards organizations. These collaborations are crucial for advancing public health through digital health innovation. Some notable partnerships include:
- FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSIs)
- Collaborative Communities on various digital health topics
- CDRH’s Network of Digital Health Experts
- Partnership with the Medical Device Innovation Consortium (MDIC)’s Digital Health Initiative
Research Through Collaborations
Through these partnerships, CDRH’s DHCoE is advancing regulatory science research in several key areas. Some of the research topics include:
- Assessing the robustness of clinical machine learning models
- Data science methods for post-marketing surveillance of AI diagnostic tools
- Benefit-risk preferences for AI/ML in imaging diagnostics
- Patient and provider informed labeling of AI/ML-based software
- Development and deployment of digital measures
- Integrating sensor-generated data into clinical research and patient care
These research projects demonstrate CDRH’s commitment to understanding and regulating digital health technologies effectively. By collaborating with various stakeholders, CDRH aims to foster innovation while ensuring the safety and efficacy of digital health products.
For more information on how to collaborate with CDRH’s DHCoE or to submit questions related to current digital health policies, please visit the DHCoE webpage and use the ‘Ask a Question About Digital Health Regulatory Policies’ feature.
