Final rule · 2026-22593

Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

The Food and Drug Administration (FDA) is classifying the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the digital cervical cytology slide imaging system with artificial intelligence algorithm. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.