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The US Food and Drug Administration has placed the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II under special controls, effective 5 November 2026.
✦ AI SUMMARY 30-second read
- The classification was made applicable from 31 January 2024, following a De Novo request submitted by Hologic Inc. on 27 August 2021.
- The device is a prescription in vitro diagnostic system that uses machine learning to flag areas of interest on Pap test slides to aid cytology diagnosis.
- Class II placement means future substantially equivalent devices may enter the market through the less demanding 510(k) pathway rather than full premarket approval.
Why it matters: The ruling lowers the regulatory bar for comparable AI-assisted cervical screening devices, potentially broadening patient access to innovative diagnostic tools.
This summary was generated by AI. Editors may review and update it.
Document details
| Document type | Rules & Regulation |
|---|---|
| Issued by | US Health and Human Services Department, Food and Drug Administration |
| Region | Global |
| Published | 5 November 2026 |
The Food and Drug Administration, under the US Department of Health and Human Services, has issued a final order classifying the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II, subject to special controls. The order is effective 5 November 2026, though the classification itself was applicable from 31 January 2024.
The action followed a De Novo classification request that FDA received from Hologic Inc. on 27 August 2021, concerning the company's Genius Digital Diagnostics System with the Genius Cervical AI algorithm. FDA reviewed the request against statutory criteria before issuing its classification order to the requester on 31 January 2024.
The final order codifies the device type at 21 CFR 864.3900, giving the generic category a formal place in federal regulation.
What the document says
FDA defines the device as a prescription in vitro diagnostic product consisting of an automated digital slide creation, viewing, and management system. It is intended to aid clinicians in reviewing digital images of slides prepared from Pap test specimens and conventional Pap smears by selecting and presenting areas of interest.
The AI software algorithm uses machine learning techniques to provide information about the presence, location, or characteristics of areas with clinical implications, with the aim of assisting the user in rendering a cytology diagnosis.
Because FDA has not exempted this device type under section 510(m) of the Federal Food, Drug, and Cosmetic Act, devices in this category remain subject to premarket notification requirements under section 510(k). Special controls identified in the order, together with general controls, are the measures FDA determined will provide reasonable assurance of safety and effectiveness.
Background
Any medical device not in commercial distribution before 28 May 1976 is automatically placed in class III under US law, requiring full premarket approval unless FDA acts to reclassify it. The De Novo process exists to allow classification into class I or II for novel, lower-risk devices that lack a predicate.
Under the De Novo pathway, FDA is required to classify the device by written order within 120 days of a valid request. Once classified into class I or II through this route, the device can serve as a predicate for future devices of that type, allowing subsequent sponsors to use the 510(k) process where applicable.
Who is affected
Device manufacturers seeking to market AI-assisted cervical cytology imaging systems in the United States are directly affected. Those with substantially equivalent products may now pursue the 510(k) pathway rather than submitting a full premarket approval application or a fresh De Novo request.
At the time of classification, these devices are for prescription use only, making them subject to prescription labelling requirements for in vitro diagnostic products under 21 CFR 809.10.
What happens next
The special controls and the generic device definition are now codified in federal regulation. Any manufacturer wishing to market a device within this classification must comply with those special controls to avoid automatic class III assignment.
The class II designation is intended to enhance patient access to AI-assisted cervical screening innovation while maintaining safety oversight through the established special and general controls framework.