FDA classifies mild cognitive impairment prognostic software as class II
The FDA issued a final order classifying the prognostic assessment software of mild cognitive impairment into class II with special controls, as stated in the Federal Register. The order notes that this classification should provide reasonable assurance of safety and effectiveness and may enhance patient access by reducing regulatory burdens.
Primary source
Federal Register rule, November 5, 2026
Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment
Read the source: Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment federalregister.gov
Machine-summarized from the source above; not independently reported. How we use automation