Regulators urge risk-based lifecycle approach for AI tools amid election-linked FDA uncertainty

A panel of regulatory experts at the RAPS AI in Regulatory Conference in Barcelona urged professionals using AI tools to adopt a risk-based, life-cycle perspective rather than focusing solely on validation.

They outlined detailed steps for validating AI systems and emphasized the need for ongoing monitoring to detect potential problems as the tools evolve.

The discussion also touched on how upcoming U.S. midterm elections could affect FDA leadership appointments and user-fee reauthorizations, adding uncertainty to the regulatory environment.