On November 5, 2026, the Food and Drug Administration (FDA) announced the classification of the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II (special controls). According to the FDA, this classification is intended to provide a reasonable assurance of the safety and effectiveness of the device. The order is effective as of November 5, 2026, and was applicable starting January 31, 2024.
Press Release: Food and Drug Administration
Published November 5, 2026. Reproduced in full from the Food and Drug Administration.
Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Action: Final amendment; final order.
Summary
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.
Key dates
- Takes effect: November 5, 2026
This order is effective November 5, 2026. The classification was applicable on January 31, 2024.
Full text: Federal Register document 2026-22593
