FDA regulates software predicting the future of mild cognitive impairment
Published Date: 11/5/2026
Rule
Summary
The FDA is officially putting mild cognitive impairment prognostic software into Class II, meaning it now has special safety rules but fewer hurdles than the strictest category. This change helps patients get access to these helpful tools faster and ensures the devices are safe and effective. The new rules took effect November 5, 2026, but have been in place since January 11, 2024, giving companies clear guidance on what’s expected.
Analyzed Economic Effects
5 provisions identified: 2 benefits, 2 costs, 1 mixed.
Device moved to Class II (faster access)
The FDA officially classified prognostic assessment software of mild cognitive impairment as Class II (special controls), effective November 5, 2026, with the classification applicable January 11, 2024. FDA says this Class II classification provides reasonable assurance of safety and effectiveness and will enhance patient access to these tools by reducing regulatory burdens compared with automatic Class III assignment.
Premarket 510(k) requirement remains
The device type is subject to premarket notification under section 510(k) of the FD&C Act unless FDA later exempts it; FDA has not exempted this device at this time. Companies seeking to market these devices must submit a 510(k) to reasonably assure safety and effectiveness.
Special controls require testing, labeling, and software validation
To be in Class II, these devices must meet special controls including: clinical performance testing (including accuracy, precision, reproducibility; independent test data representative of intended patients), reporting objective performance measures (e.g., sensitivity, specificity, positive/negative predictive value), software verification/validation and hazard analysis, human factors/usability assessment, physician labeling with detailed performance methods/results and limitations, and patient labeling explaining outputs and risks.
De Novo classification enables predicate for future devices
FDA used the De Novo process for this device type, meaning the device can serve as a predicate for future devices; other sponsors can rely on 510(k) pathways to market substantially equivalent devices rather than submitting new De Novo requests or premarket approval applications.
Prescription-only, adjunctive use requirement
FDA identifies prognostic assessment software of mild cognitive impairment as a prescription-only device that is intended for adjunctive use and is not a stand-alone diagnostic or prognostic tool. The device output must be interpreted in the context of all clinical information.
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Key Dates
Department and Agencies
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