FDA classifies AI-powered cervical cytology imaging device as Class II
The US Food and Drug Administration issued a final rule classifying digital cervical cytology slide imaging systems that use AI algorithms into a regulated device class with special controls.
Summary
The Food and Drug Administration (FDA) has issued a final order placing a device type in class II, which carries special controls. The device type is a digital imaging system for cervical cytology slides that uses an artificial intelligence algorithm. The notice appears in the Federal Register and is labelled a final amendment and final order.
The order states that it takes effect on November 5, 2026. It adds that the classification itself applied from January 31, 2024. The special controls for this device type are set out within the order, and they will become part of the codified wording used for classifying this cervical slide imaging device.
The FDA explains its reasoning. It says it concluded that a class II designation will give reasonable confidence that the device is safe and effective. The agency adds that it believes the step will also widen patient access to beneficial, innovative devices, partly through lighter regulatory burdens.
A footnote in the document explains the wording of the action caption, which reads final amendment, final order instead of just final order. The FDA says this editorial change has been applied since December 2019 to show that a document amends the Code of Federal Regulations, and that it follows the Office of the Federal Register's interpretations of the Federal Register Act, related regulations and its drafting handbook.