FDA’s PCCP rule for AI radiology: what patients and clinicians should know
A June 17, 2026 Federal Register final order codified a Class II (“special controls”) pathway for certain AI/ML radiology quantitative imaging software that uses an FDA-authorized Predetermined Change Control Plan (PCCP). In plain terms: when AI software updates are planned and bounded, FDA expects evidence, risk controls, and labeling—so clinicians can better understand when performance may change and how to verify results.
