Medical Devices; Neurological Devices; Classification of the Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
fda-device · Food and Drug Administration · Rule · Published 2015-03-27 · Effective 2015-03-27 · 80 FR 16266
Document
Document number
2015-07010
Federal Register citation
80 FR 16266
CFR reference
21 CFR 882
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-03-27
Effective date
2015-03-27
HHS docket
Docket No. FDA-2015-N-0802
Abstract
The Food and Drug Administration (FDA) is classifying the brain injury adjunctive interpretive electroencephalograph assessment aid 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 brain injury adjunctive interpretive electroencephalograph assessment aid'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.