Food and Drug Administration
Protects public health by regulating food, drugs, medical devices, and cosmetics.
2 regulationsClinical Decision Support Software Utilizing Artificial Intelligence and Machine Learning; Updated Regulatory Framework
This proposed rule establishes an updated regulatory framework for clinical decision support software that uses artificial intelligence and machine learning. It creates a tiered classification system based on the clinical risk level of the AI's intended use and introduces a predetermined change control plan pathway that allows manufacturers to update algorithms without requiring new premarket submissions for each modification.
Medical Devices; Laboratory Developed Tests; Phased Oversight Framework
This final rule phases out the FDA's longstanding enforcement discretion for laboratory developed tests (LDTs) and brings them under the same regulatory framework as other in vitro diagnostics. The rule implements a four-year phaseout period, beginning with adverse event reporting requirements and culminating in full premarket review for high-risk tests.