FDA Updates Guidance for AI/ML in Medical Devices, Including Predetermined Change Control Plans

The U.S. Food and Drug Administration (FDA) has updated its Center for Devices and Radiological Health (CDRH) guide, which now includes standardized protocols for artificial intelligence and machine learning (AI/ML) software functions, known as Predetermined Change Control Plans (PCCP). This regulatory development is significant for patient safety and the healthcare system, as it outlines pathways for premarket clearance or approval and ensures reasonable assurance of safety and effectiveness for novel low-to-moderate risk devices utilizing AI/ML.