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FDA classifies mild cognitive impairment prognosis software

FDA published a final order classifying prognostic assessment software for mild cognitive impairment as class II with special controls. The prescription-only software combines clinical data to estimate the chance a person with mild cognitive impairment will progress to more severe impairment or dementia such as Alzheimer’s within a set time. It is adjunctive only—not a stand-alone diagnostic—and labeling must warn against over-reliance on the output.

Who it covers

Everyone

Official source

U.S. Food and Drug Administration (Federal Register)

Checked on

November 12, 2026. We opened the official page and confirmed the wording and every number.

not intended as a stand-alone diagnostic or prognostic tool