# 2026-22593: FDA Gives AI Cervical Slide Readers a Regulatory Category

2026-22593, Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-11-05, effective 2026-11-05; PRIA reads it as touching household money (as of 2026-11-06).

- Canonical: https://policyrisk.com/federal-register/2026-22593
- As of: 2026-11-06
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-22593
- Title: Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 69687
- Published: 2026-11-05
- Effective: 2026-11-05
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-06

## In one line

FDA Gives AI Cervical Slide Readers a Regulatory Category

## Summary

The FDA is officially classifying digital cervical cytology slide imaging systems with AI as class II devices, meaning they have special safety rules but fewer regulatory hurdles. This change helps make these smart medical tools safer and easier to get to patients, starting November 5, 2026, with the classification effective retroactively from January 31, 2024. Labs and device makers will benefit from clearer rules and faster access to innovative tech without extra costs.

## 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.

## Effects PRIA read

- AI Pap Test Systems Reach Patients Faster: benefit, medium. You may get earlier access to AI-assisted Pap test slide imaging because the FDA classified these systems as Class II (special controls), with the order effective November 5, 2026 and the classification applicable January 31, 2024. The FDA says this reclassification will enhance patients' access to…
- Easier 510(k) Path for Future Devices: benefit, medium. If you make these devices, the De Novo classification means this device type can serve as a predicate for future devices, allowing sponsors to use the less-burdensome 510(k) premarket notification process instead of premarket approval. The FDA issued the De Novo order January 31, 2024 and codified…
- New Testing, Labeling, and 510(k) Requirements: cost, high. If you develop or market these systems, they are prescription in vitro diagnostic devices and are subject to premarket notification under section 510(k). You must meet the final order's special controls, including detailed labeling (intended use, patient population, training), extensive design veri…

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## Sources
- [2026-22593 on federalregister.gov](https://www.federalregister.gov/documents/2026/11/05/2026-22593/medical-devices-hematology-and-pathology-devices-classification-of-the-digital-cervical-cytology)
- [2026-22593 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-11-05/pdf/2026-22593.pdf)

## Related
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Source: PRIA, https://policyrisk.com/federal-register/2026-22593 (as of 2026-11-06).