The FDA recently published two draft guidelines regarding the use of AI in the creation of drugs and biologicals and medical devices.
The first draft guidance provides recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. This is the first guidance the agency has issued on the use of AI for the development of drug and biological products.
Since 2016, the use of AI in drug development and in regulatory submissions has exponentially increased. AI can be used in various ways to produce data or information regarding the safety, effectiveness, or quality of a drug or biological product.
A key aspect to the appropriate application of AI modeling in drug development and regulatory evaluation is ensuring model credibility. Given the range of potential applications of AI modeling, defining the model’s context of use is critical. For this reason, this guidance provides a risk-based framework for sponsors to assess and establish the credibility of an AI model for a particular context of use and determine the credibility activities needed to demonstrate that an AI model’s output is credible.
This approach is consistent with how FDA staff have been reviewing applications for drug and biological products with AI components. The FDA encourages sponsors to have early engagement with the agency about AI credibility assessment or the use of AI in human and animal drug development.
Public comments on the guidance will be accepted by the FDA by April 7, 2025.
The second draft guidance includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s total product life cycle.
If finalized, these guidelines would provide developers an accessible set of considerations that tie together design, development, maintenance and documentation recommendations to help ensure safety and effectiveness of AI-enabled devices.
The draft guidance includes recommendations for how and when, in marketing submissions, sponsors should describe the post-market performance monitoring and management of their AI-enabled devices.
The guideline also includes the FDA’s current thinking on strategies to address transparency and bias throughout the life cycle of AI-enabled devices, with specific recommendations intended to help sponsors demonstrate they have addressed risks associated with bias, providing suggestions for the thoughtful design and evaluation of AI-enabled devices.
The FDA will hold a webinar on February 18, 2025 to discuss the draft guidance and is inviting stakeholders to contribute public feedback on the draft guidance by April 7, 2025.
