Citation

Fed. Regist. 2016; 81(234): 87810-87812.

Copyright

(Copyright © 2016, U.S. Office of the Federal Register, National Archives and Records Service, General Services Administration)

DOI

unavailable

PMID

27992155

Abstract

The Food and Drug Administration (FDA) is classifying the Computerized Cognitive Assessment Aid for Concussion into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the computerized cognitive assessment aid for concussion's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Language: en