FDA classifies mild cognitive impairment prognostic assessment software as Class II
Federal Register rule 2026-22590, effective 5 November, sets Class II special controls for prognostic assessment software of mild cognitive impairment; the classification applied from 11 January 2024.
Why it matters
Putting mild cognitive impairment prognostic software into Class II with special controls is another step in FDA's pattern of moving AI/ML clinical decision software out of default Class III once special controls exist. The tool is adjunctive only — it estimates likelihood of progression, not a stand-alone diagnosis — which matches how clinics actually use risk scores. Watch which commercial products map to 21 CFR 882.1454 and how payers treat prognostic AI outputs in memory clinics.
Key facts
- Federal Register rule 2026-22590 effective 5 Nov 2026
- Device: prognostic assessment software of mild cognitive impairment
- Class II with special controls; adds 21 CFR 882.1454
- Classification applicable since 11 January 2024
- Adjunctive only; not a stand-alone diagnostic
- Combines multiple clinical data sources for progression likelihood