The U.S. Food and Drug Administration (FDA) published a document titled "Artificial Intelligence & Medical Products", which details how the agency's medical product Centers are working together to ensure the safe and responsible use of artificial intelligence (AI) in the development and regulation of medical products. The Centers involved in this collaboration include the 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).
The FDA acknowledges the potential of AI to revolutionize health care by advancing medical product development, improving patient care, and augmenting the capabilities of health care practitioners. The agency is committed to supporting innovative work in the development and regulation of medical products while safeguarding public health.
Four Areas of Focus
The document outlines four key areas of focus for the FDA's medical product Centers regarding the development and use of AI across the medical product life cycle:
1. Fostering collaboration with stakeholders, including developers, patient groups, academia, and global regulators, to cultivate a patient-centered regulatory approach that emphasizes collaboration and health equity.
2. Advancing the development of regulatory approaches that support innovation by providing regulatory predictability and clarity for the use of AI in medical products.
3. Promoting the development of standards, guidelines, best practices, and tools for the medical product life cycle, building on the agency's Good Machine Learning Practice Guiding Principles.
4. Supporting research related to the evaluation and monitoring of AI performance, including demonstration projects that identify and address bias, consider health inequities, and ensure adherence to standards throughout the AI life cycle.
Regulatory Approaches and Guidance
The FDA plans to align efforts across its medical product Centers to develop policies, guidance, and regulatory approaches that provide clarity and predictability for the use of AI in medical products. This includes leveraging existing initiatives, supporting regulatory science efforts, and issuing guidance on various aspects of AI use in medical product development and in medical products.
The agency intends to issue guidance on topics such as marketing submission recommendations for predetermined change control plans for AI-enabled device software functions, life cycle management considerations and premarket submission recommendations for AI-enabled device software functions, and considerations for the use of AI to support regulatory decision-making for drugs and biological products.
The FDA emphasizes its commitment to promoting the responsible and ethical development, deployment, use, and maintenance of medical products that incorporate or are developed with AI, while ensuring patient access to safe and effective medical products. As AI is a rapidly progressing field, the agency anticipates that its actions may evolve as it pursues these activities and maintains open channels for engagement with both U.S. and global parties.
/Passle/6488db705f4287c6f3e7c2d7/SearchServiceImages/2024-04-24-18-35-06-214-662950dad510b689bb669354.jpg)
/Passle/6488db705f4287c6f3e7c2d7/MediaLibrary/Images/64af07f9786af1eb1ef08494/2023-08-08-02-03-44-018-64d1a280ff74305060de0500.jpg)
/Passle/6488db705f4287c6f3e7c2d7/SearchServiceImages/2024-04-18-20-37-34-334-6621848e04164acc7320b685.jpg)
/Passle/6488db705f4287c6f3e7c2d7/SearchServiceImages/2024-04-18-15-15-50-207-66213926d52a0531835f4237.jpg)