FDA's AI/ML regulatory framework proposal (2019)
The FDA published a discussion paper proposing a regulatory framework for AI/ML-based software as a medical device. It introduced the concept of a predetermined change control plan, allowing algorithms to learn and improve post-market within pre-approved bounds.
The framework went through stakeholder feedback and refinement over several years.
PCCP became an official regulatory tool, now appearing in clearances like Heartvue.Proton.
This clearance is the practical implementation of a concept the FDA proposed seven years earlier.
