Medical Devices; Neurological Devices; Classification of the Neuropsychiatric Interpretive Electroencephalograph Assessment Aid
fda-device · Food and Drug Administration · Rule · Published 2014-02-18 · Effective 2014-03-20 · 79 FR 9083
Document
Document number
2014-03388
Federal Register citation
79 FR 9083
CFR reference
21 CFR 882
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-02-18
Effective date
2014-03-20
HHS docket
Docket No. FDA-2013-M-0042
Abstract
The Food and Drug Administration (FDA) is classifying the neuropsychiatric interpretive electroencephalograph (EEG) assessment aid into class II (special controls). 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.