FDA Publishes Paper Identifying Focus Areas for “Responsible Use of AI” in Medical Products

In March 2024, the U.S. Food and Drug Administration (FDA) published a paper titled, “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH and OCP are Working Together,” that discusses the agency's ongoing efforts to address the implications of artificial intelligence (AI) in the medical products industry. While the paper makes clear that the FDA is engaged in an “iterative” process to determine how best to approach AI regulation, it nonetheless provides some valuable insights for medical device manufacturers, drug manufacturers and other companies.

Four “Areas of Focus” for Addressing AI in the Medical Products Industry

The FDA’s paper outlines four “areas of focus” for fostering “responsible use of AI in medical product development and in medical products.” As the paper explains, the 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 working together to formulate a regulatory approach that, “to the extent feasible, can be applied across various medical products and uses within the health care delivery system.” With this end goal in mind, the four “areas of focus” are:

#1: Fostering Collaboration to Safeguard Public Health

To address the implications of AI in the medical products industry, the FDA intends to, “solicit input from a range of interested parties to consider critical aspects of AI use in medical products.” This means that medical device manufacturers, drug manufacturers and other companies will have the opportunity to play a meaningful role in determining the FDA’s approach going forward.

#2: Advancing the Development of Regulatory Approaches that Support Innovation

The FDA’s paper makes clear that the agency aim is to regulate rather than restrict—with the ultimate goal of “support[ing] innovation” in the industry. To this end, the paper indicates that the FDA intends to:

• Monitor and evaluate trends in the industry;

• Support efforts to develop methodologies for evaluating AI algorithms;

• Leverage existing initiatives related to AI regulation; and,

• Issue guidance on the use of AI in regulatory decision-making, life cycle management, and device software functions.

#3: Promoting the Development of Standards, Guidelines, Best Practices and Tools for the Medical Product Life Cycle

In the same vein of fostering innovation rather than restricting it, the FDA’s paper indicates that the agency will focus much of its effort on developing standards, guidelines and best practices for implementing AI in the medical product industry. The paper also indicates that the FDA intends to develop “a framework and strategy for quality assurance of AI-enabled tools or systems used in the medical product life cycle.”

#4: Supporting Research Related to the Evaluation and Monitoring of AI Performance

The paper also indicates that the FDA intends to support demonstration projects that identify both risks and opportunities associated with the use of AI in the development of medical devices, drugs and other medical products. Here, too, this suggests that industry participants will have significant opportunities to engage with the FDA as it works to develop its initial regulatory framework for the use of AI in the medical products industry.

Given the FDA paper, along with recent remarks from FDA leaders as well as the White House, it is clear that regulation of AI in healthcare is on the government’s radar. While the full extent of potential changes remains to be seen, it is clear the agency is focusing on creating tailored rules for this rapidly evolving technology. With potential new legislation on the horizon, we could see anything from minor adjustments to significant overhauls in how AI-powered medical products are developed and used. We are keeping a close eye on this evolving situation.

Contact Gardner Law for More Information

The attorneys at Gardner Law represent medical device manufacturers, drug manufacturers and other companies in all FDA-related regulatory and compliance matters. Contact us to learn more.