FDAs Warning Letter Suggests Growing Scrutiny of AI Overreliance

A recently issued Food and Drug Administration (FDA) Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is expanding. Although not the first FDA Warning Letter related to AI, prior Warning Letters focused on issues surrounding the regulatory status of the AI systems themselves, namely whether a given AI system was a medical device subject to FDA oversight. This Warning Letter, however, indicates FDA is now scrutinizing the use... By: Morgan Lewis - As Prescribed