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Artificial Intelligence Oversight At FDA Will Require Continuous Algorithm Validation, Califf Says

 
• By Derrick Gingery

US FDA commissioner says stakeholders could help write AI regulations, but the agency would retain the final say of which to implement. FDA cannot regulate artificial intelligence for decision support, but can be involved when algorithms could impact patient safety.

artificial intelligence
Robert Califf said industry needs to be more accountable for the FDA to deal with AI. • Source: Shutterstock

As more AI and machine learning-related applications reach the US Food and Drug Administration, regulators and stakeholders likely will be working together on validation and standards development, but the agency will remain the final arbiter of regulations that are written, Commissioner Robert Califf said.

Key Takeaways
  • Califf envisions a continuous regulatory effort in which standards are developed collaboratively with industry, enacted by FDA, and monitored by a consortium.
  • Agency staffing and industry transparency could be major stumbling blocks for the effort

Califf told the Alliance for a Stronger FDA on 31 January that the agency still retains authority on which standards to implement, but both sides likely would

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