In January 2025, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or quality; and (2) the development and marketing of safe and effective AI-enabled devices.
Drug & Biological Products Guidance
The use of AI to produce data and information supporting regulatory filings regarding safety, effectiveness, and quality of drugs faces challenges such as dataset bias, model opacity, output accuracy verification, and performance drift. To mitigate these, FDA proposes a risk-based credibility assessment framework featuring seven steps: defining the AI model’s role and scope (steps 1-2), assessing model risk based on influence and consequences (step 3), creating and executing a credibility assessment plan (steps 4-6), and evaluating the model’s adequacy for its specific use (step 7). The guidance emphasizes maintaining AI credibility throughout a product’s life cycle and provides hypothetical examples in clinical development and manufacturing.
Medical Device Guidance
The FDA’s second draft guidance outlines requirements for marketing submissions for medical devices with AI-enabled software functions. This guidance includes FDA’s current thinking on transparency and bias in FDA’s Total Product Life Cycle of AI-enabled devices. FDA provides recommendations and rationales for, among other things, risk assessment, data management, and performance validation. The guidance explains that sponsors must provide detailed information covering device uses, inputs, outputs, architecture, development, performance, installation, and maintenance in both submissions and product labels.
Takeaways
- Sponsors implementing AI solutions for drug or biologic safety, effectiveness, or quality information should consider FDA’s credibility assessment framework when designing and training their AI model.
- Sponsors seeking approval for medical devices containing AI components should evaluate FDA’s requirements over a product’s predicted lifetime.
- Early engagement between the company’s AI experts and in-house counsel is key to ensure a sponsor is meeting all of FDA’s requirements to move a product to market.
Updates
The public comment period during which the FDA requested feedback on: (1) performance metrics and indicators, (2) real-world evaluation methods and infrastructure, (3) post-market data sources and quality management, (4) monitoring triggers and response protocols, (5) human-AI interactions and user experience, and (6) additional considerations and best practices closed on December 1, 2025. Public feedback can be found here: Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World.
Read our original client alert, FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products.
This article appeared in the 2025 AI Intellectual Property: Analysis & Trends Year in Review report.
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