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...
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 have to collaborate...
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