The Food and Drug Administration (FDA) is classifying the prognostic assessment software of mild cognitive impairment into class II (special controls) as of November 5, 2026. According to the FDA, this classification will provide a reasonable assurance of the safety and effectiveness of the device and enhance patients' access to beneficial innovative devices. The classification was applicable on January 11, 2024, and the full text is available in the Federal Register document.
Press Release: Food and Drug Administration
Published November 5, 2026. Reproduced in full from the Food and Drug Administration.
Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment
Action: Final amendment; final order.
Summary
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.
Key dates
- Takes effect: November 5, 2026
This order is effective November 5, 2026. The classification was applicable on January 11, 2024.
Full text: Federal Register document 2026-22590
