2026-22593·DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

Final RuleEffective

Published: Nov 5, 2026
Effective: Nov 5, 2026
Citation: 91 FR 69687
Docket: Docket No. FDA-2026-N-12384
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final amendment; final order.

Summary

The Food and Drug Administration (FDA) has placed digital cervical‑cell imaging systems that use artificial‑intelligence (AI) algorithms into the FDA’s Class II category. Class II devices are considered moderate‑risk and are subject to “special controls”—specific performance standards and testing requirements that the agency has identified for this technology. The FDA says this classification will help ensure the safety and effectiveness of the devices while also making it easier for manufacturers to bring innovative AI‑driven tools to market and improving patient access to modern screening methods. The rule was issued by the Department of Health and Human Services, specifically the FDA, and it applies to manufacturers of digital cervical cytology slide‑imaging systems that incorporate AI algorithms. By being re‑classified, these companies will need to follow the newly defined special controls but will no longer be subject to the more burdensome pre‑market approval process required for higher‑risk devices. The regulation was published in the Federal Register on November 5, 2026 (91 FR 69,687) and became effective the same day, November 5, 2026. With the final rule now in force, manufacturers must align their product development, testing, and labeling with the specified special controls. The FDA will monitor compliance and may issue guidance or conduct inspections as needed to confirm that the devices continue to meet safety and performance standards.

AI-generated summary — verify against the Federal Register text.

Official abstract

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.