Artificial intelligence or AI isn’t going anywhere, and the FDA is the latest agency to recognize its potential to revolutionize healthcare by advancing medical product development, improving patient care, and expanding the capabilities of healthcare practitioners in its new paper, “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” The paper seeks to provide greater transparency regarding how FDA’s medical product Centers[1] are collaborating to safeguard public health while fostering responsible and ethical innovation. Developed to reaffirm the FDA’s commitment to promoting the development, deployment, use, and maintenance of medical products that incorporate or are developed with AI, the paper describes the actions that these Centers are taking or intend to take regarding the uses of AI across the medical product life cycle, and is organized around the following four areas of focus: (i) Fostering Collaboration to Safeguard Public Health, (ii) Advance the Development of Regulatory Approaches that Support Innovation, (iii) Promote the Development of Harmonized Standards, Guidelines, Best Practices, and Tools, and (iv) Support Research Related to the Evolution and Monitoring of AI Performance.
With respect to Fostering Collaboration to Safeguard Public Health, the Agency intends to:
- solicit input to consider critical aspects of AI use in medical products;
- promote the development of educational initiatives that will assist with navigating the safe and responsible use of AI; and
- work with global collaborators to promote international cooperation on standards, guidelines, and best practices to encourage consistency and convergence in the use of AI.
With respect to Advancing the Development of Regulatory Approaches that Support Innovation, the Centers intend to develop policies that provide regulatory predictability and clarity for the use of AI, which includes:
- monitoring and evaluating trends and emerging issues;
- supporting regulatory science efforts;
- leveraging and building upon existing initiatives for the evaluation and regulation of AI use in medical products and in medical product development, including manufacturing; and
- issuing guidance for the use of AI in medical product development, including but not limited to:
- financial guidance on marketing submissions;
- guidance on life cycle management considerations and premarket submission recommendations; and
- guidance on considerations for the use of AI to support regulatory decision making for drugs and biological products.
With respect to Promoting the Development of Harmonized Standards, Guidelines, Best Practices, and Tools, the Agency will:
- continue to refine and develop considerations for evaluating the safe, responsible, and ethical use of AI in the medical product life cycle;
- promote best practices for long-term safety and real-world performance monitoring of AI-enabled medical products;
- explore best practices for documenting and ensuring that data used to train and test AI models are fit for use; and
- develop a framework and strategy for quality assurance of AI-enabled tools or systems used in the medical product life cycle.
Finally, with respect to Supporting Research Related to the Evolution and Monitoring of AI Performance, the Centers plan to support projects that:
- highlight different points where bias can be introduced in the AI development life cycle and how it can be addressed;
- consider health inequities associated with the use of AI in medical product development; and
- monitor the use of AI tools in medical product development within demonstration projects to ensure adherence to standards.
[1] The Food and Drug Administration’s (FDA’s) 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 jointly publishing this paper and are referred to as the “FDA’s medical product Centers” or “Centers.”
