FDA invites feedback to ensure safety and reliability of AI tools in healthcare.

The U.S. Food and Drug Administration (FDA) is asking the public to weigh in on how artificial intelligence (AI)-enabled medical devices should be evaluated for long-term safety and effectiveness. The agency released a notice this week seeking comments on methods to monitor, assess, and address changes in device performance as they are used in real-world healthcare settings.

As AI technology evolves, medical devices powered by these systems may adapt or behave differently over time. The FDA aims to establish clear strategies for detecting and mitigating such shifts to make sure the tools remain reliable throughout their life cycle.

“This feedback will help shape oversight that both protects patients and supports innovation,” the agency said in its announcement.

The call for input comes shortly after the White House Office of Science and Technology Policy issued its own request for public comment, asking stakeholders to identify federal rules that may slow AI development and adoption. Together, these efforts highlight the government’s growing focus on balancing innovation with safety in the rapidly advancing field of AI in healthcare.

The FDA will accept comments until December 1 through its official portal at www.regulations.gov. Patients, healthcare providers, developers, and industry leaders are all encouraged to share their perspectives.

By engaging the public, the FDA hopes to create a collaborative path forward that ensures AI-driven devices deliver on their promise without compromising trust or safety.