AI Claims — Yay or Oy? A Recent Warning Letter Tells a Cautionary Tale

A recent Food and Drug Administration Warning Letter offers a timely reminder that how a digital health product is promoted can be just as consequential as how it functions. An August 2025 Warning Letter, issued after an FDA inspection, identified promotional claims for a software-based health product that, in the agency’s view, crossed into diagnostic territory — largely due to references to artificial intelligence….
By: Arnall Golden Gregory LLP