Lexology January 4, 2023
Artificial intelligence (AI) technology is increasingly being used in the healthcare field, and the US Food and Drug Administration (FDA) plays a crucial role in regulating these applications. Below, we examine the different ways that the FDA regulates AI technology in healthcare and look at some of the challenges and opportunities presented by this rapidly evolving field.
To understand how the FDA regulates AI technology, it’s important to first understand the agency’s definition of a “device”, which is a product-by-product determination, based on the intended use.
According to the Federal Food, Drug, and Cosmetic Act (FDCA), a device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or...
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