The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or information that supports regulatory decision-making in submissions for drugs and biological products.
In the draft guidance, FDA proposes using a risk-based credibility assessment framework for AI use in product submissions based on context of use (COU). The framework would apply when AI produces information or data that would lead to a regulatory decision of a product’s safety, effectiveness, and/or quality. Activities to establish credibility, such as FDA oversight, stringency of the credibility assessment, risk mitigation, the sponsor, performance acceptance criteria, and documentation, are specific to the COU and should be appropriate based on the AI model risk…
