FDA classifies AI digital cervical cytology slide imaging systems as Class II devices
Federal Register rule 2026-22593, effective 5 November, sets special controls for digital cervical cytology slide imaging systems with an AI algorithm; the classification applied from 31 January 2024.
Why it matters
Codifying digital cervical cytology with AI as Class II with special controls lowers the default Class III barrier and should speed follow-on clearances that use similar algorithms to flag Pap-slide regions of interest. The order is administrative as much as clinical: the underlying classification already applied in January 2024, and today's Federal Register text makes the special controls public. Watch which vendors cite 21 CFR 864.3900 in new 510(k)s and whether labs shift more cytology volume to AI-assisted digital workflows.
Key facts
- Federal Register rule 2026-22593 effective 5 Nov 2026
- Device: digital cervical cytology slide imaging with AI algorithm
- Class II with special controls; adds 21 CFR 864.3900
- Classification applicable since 31 January 2024
- Intended to aid Pap-slide review by presenting areas of interest
- Prescription in vitro diagnostic device