The Food and Drug Administration is considering evaluating generative AI-enabled medical devices through a “competency-based approach,” similar to how doctors are evaluated, the agency writes in a discussion paper first shared with Axios. Emerging medical technologies are challenging the existing framework for overseeing medical devices, prompting calls for new approaches. The FDA’s discussion paper raises considerations for both preapproval and postmarket regulation of AI-enabled devices and solicits stakeholder feedback.
Read the full article: FDA Considers Assessing AI Devices Like Doctors //
Source: https://www.axios.com/2026/08/18/fda-doctor-ai-medical-devices-review