On March 15, 2024, the U.S. Food and Drug Administration (FDA) published a white paper detailing its collaborative efforts to establish regulatory frameworks for the responsible use of artificial intelligence (AI) in medical products. The FDA’s focus spans four key areas in relation to AI throughout the medical product life cycle:
- Enhancing Collaboration: The agency aims to foster partnerships to ensure public health is protected.
- Supporting Innovation: The FDA is committed to advancing regulatory strategies that encourage the development of innovative medical products.
- Developing Standards and Best Practices: It will promote the creation of guidelines, tools, and practices pertinent to the entire medical product life cycle.
- Encouraging Research: The agency plans to support research initiatives aimed at evaluating and monitoring AI performance.
The white paper also indicates that in 2024, the FDA will release draft guidance on lifecycle management and premarket submission processes for AI-enabled medical devices. Additional draft guidelines will address AI’s role in regulatory decision-making concerning drugs and biological products. Final guidance will be provided on marketing submissions related to predetermined change control plans. Moreover, the FDA will initiate demonstration projects to identify and mitigate bias in AI development, tackle health inequities related to AI, and ensure continuous monitoring to uphold standards and reliability.
Why It Matters: Stakeholders involved in developing and marketing AI-enabled medical devices should pay close attention to the forthcoming guidance from the FDA. Understanding these regulations is crucial as they may affect market entry strategies and compliance obligations for innovative technologies. Increased scrutiny from the FDA and other federal health agencies is anticipated regarding these advancements.
To access the full white paper from the FDA and gain detailed insights into their regulatory approaches for AI in medical devices, white paper.
