FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; NEUROLOGICAL DEVICES; CLASSIFICATION OF THE PROGNOSTIC ASSESSMENT SOFTWARE OF MILD COGNITIVE IMPAIRMENT

WASHINGTON, Nov. 5 -- Food and Drug Administration has issued a rule called: Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment.

The rule was published in the Federal Register on Nov. 5 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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 beca...