The U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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.
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.
The FDA’s medical product centers have a shared commitment to promote the responsible and ethical use of AI for medical products. As the field of AI evolves, the agency will continue to develop policies that support innovation and uphold the agency’s rigorous standards for safety and effectiveness.
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