2026-22590·DEPARTMENT OF HEALTH AND HUMAN SERVICES

Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment

Final RuleEffective

Published: Nov 5, 2026
Effective: Nov 5, 2026
Citation: 91 FR 69690
Docket: Docket No. FDA-2026-N-12212
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final amendment; final order.

Summary

The Food and Drug Administration (FDA) is officially placing software that predicts the progression of mild cognitive impairment (MCI) into a “class II” category of medical devices. Class II devices are subject to specific “special controls”—additional requirements such as performance testing and labeling standards—designed to ensure they are safe and work as intended. The FDA believes these controls will provide reasonable assurance of safety and effectiveness while also streamlining the pathway for innovative tools that can help patients and clinicians manage early cognitive decline. This rule is issued by the U.S. Department of Health and Human Services, specifically the FDA, and it applies to manufacturers and developers of prognostic assessment software for MCI. By defining the device’s classification and the applicable special controls, the agency clarifies what evidence and documentation companies must provide before the software can be marketed in the United States. The regulation was published and became effective on November 5, 2026 (91 FR 69690). Because it is a final rule, there is no further comment period; the special controls outlined in the order are now part of the federal classification system. Companies will need to align their products with these controls to obtain or maintain clearance, and the FDA will begin reviewing submissions under the new class II framework.

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Official abstract

The Food and Drug Administration (FDA) is classifying the prognostic assessment software of mild cognitive impairment 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 prognostic assessment software of mild cognitive impairment. 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.