FDA Takes Hands-Off Approach to AI Devices and Software
AI Summary
The FDA will not regulate AI-enabled health wearables and clinical decision support software if they meet certain low-risk criteria; this guidance aims to foster market innovation.
Texas Relevance
The article does not mention Texas, TCUD, or any Texas-specific entities. It is a general federal regulatory update.
Original Content
Agency: Guidance Favors Market Innovation Over Federal Scrutiny 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.