Artificial Intelligence and Medical Products
What is Artificial Intelligence?
Artificial Intelligence (AI) is a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments. AI systems use machine- and human-based inputs to perceive real and virtual environments; abstract such perceptions into models through analysis in an automated manner; and use model inference to formulate options for information or action. AI includes machine learning, which is a set of techniques that can be used to train AI algorithms to improve performance of a task based on data.
How does AI intersect with Medical Products?
AI has emerged as a transformative force. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. This landing page serves as your gateway to a wealth of information, resources, and insights into the intersection of AI and medical products. Learn more about how the FDA is shaping the future of health care through the responsible and innovative integration of AI.
How Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) are working together?
For specific information related to biological products, please visit:
For specific information related to drug products, please visit:
For specific information related to devices, please visit:
- Digital Health Center of Excellence
- Artificial Intelligence Program: Research on AI/ML-Based Medical Devices
For more information on the laws, regulations, executive orders, and memoranda that drives HHS's AI efforts, please visit: