aceMedical 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 prov…
FDA says placing AI-assisted Pap test slide review systems in class II instead of automatic class III should widen patient access to the devices by lowering regulatory burdens.
FDA's expected gain in patient access is a stated belief, and the agency lists false negative and false positive results from device errors or user misinterpretation as the identified risks that special controls must mitigate.
Sources
- GovernmentFederal Register (Health and Human Services Department)2026-11-05
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Truvace Impact Record TRV-2026-2417, v1: “Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm.” Truvace, 2026-11-07. /record/TRV-2026-2417 (accessed on the day you copy it). sha256 6032d93090d96a78…
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