FDA Takes Hands-Off Approach to AI Devices and Software

Agency: Guidance Favors Market Innovation Over Federal Scrutiny Marianne Kolbasuk McGee (HealthInfoSec) • January 7, 2026

New artificial intelligence-enabled health wearable devices and clinical decision support software will not face U.S. Food and Drug Administration regulatory scrutiny, providing the technology meets certain criteria, such as being "low-risk," the agency said this week.

See Also: Going Beyond the Copilot Pilot - A CISO's Perspective

The policy stance is spelled out in two new and separate guidance documents, and in statements by agency leadership.

The FDA published two non-binding guidance documents to coincide with public comments by FDA Commissioner Marty Makary during the Consumer Electronics Show in Las Vegas on Tuesday and in an interview with Fox Business that same day, which Makary also reposted ...