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

5 November 2026

In plain English

FDA classifies prognostic assessment software of mild cognitive impairment devices into class II with special controls, effective as stated in the order.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
5 November 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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.

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