Foley & Lardner LLP partner Kyle Faget is quoted in the Corporate Counsel article, “FDA Plan for Reviewing AI-Enabled Medical Devices Isn’t Quite Computing,” commenting on the need from makers of medical devices for clarity from the U.S. Food and Drug Administration on its approval framework for devices evolving in real time.
Faget, who is chair of Foley’s Medical Devices area of focus within the firm’s Health Care & Life Sciences Sector and co-chair of the firm’s Health Care Practice, said, “FDA’s current regulatory framework works well for medical devices that undergo iterative improvement over time or serially, but not so much for devices that are evolving/iterating in real time as is the case with machine learning devices.”
Foley’s client advisory on the topic, cited in the Corporate Counsel article, noted that the current process “is not well suited for the faster iterative design and development, and type of validation used for software device functions.”
“I think the FDA is struggling to get its arms around how to regulate it,” Faget continued. “We’re really in the nascent stage with AI.”
“[It’s] very frustrating for innovators because it takes time to go through the regulatory process. My clients are pushing the boundaries all of the time,” Faget added. “I have to say, ‘That’s fine, but we’re going to have to approach the FDA about it.’”