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

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FDA issued a final order (FR Doc. 2026-22593, Docket No. FDA-2026-N-12384) classifying the digital cervical cytology slide imaging system with artificial intelligence algorithm as a class II device with special controls. It adds 21 CFR 864.3900. The order is effective November 5, 2026. The classification itself applied from January 31, 2024. It follows Hologic Inc.'s De Novo request, received August 27, 2021, for the Genius Digital Diagnostics System with the Genius Cervical AI algorithm. The device is a prescription in vitro diagnostic. It creates and manages digital slide images from Pap tests and conventional Pap smears. Its machine-learning algorithm selects and presents areas of interest to help the user make a cytology diagnosis. FDA identified two risks: false negative and false positive results from device errors in presenting abnormal cells, and the same results from users misinterpreting images or operating the device incorrectly. The special controls in 864.3900(b) address these risks. (1) Labeling must cover intended use, patient population, instructions for use, a device description, a summary of performance testing, screening-time data, and limiting statements. The limiting statements include that the user should review the entire gallery before diagnosing. (2) Design verification and validation must include component and system-level technical assessments, and a description of the software and its training and validation datasets. They must also include analytical studies, including precision and reproducibility across scanners, operators and sites. Clinical validation must show that device-assisted reading is non-inferior to a comparator such as an optical microscope, and must compare users with and without the AI. Screening-time data must be used to set recommended daily workload limits. Human factors study data is also required. Devices of this type remain subject to 510(k) premarket notification, because FDA has not exempted them under section 510(m). Future similar devices can use this device as a predicate, which avoids a De Novo request or premarket approval application. FDA found no significant environmental effect. It said the collections of information refer to previously approved OMB control numbers.

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