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2015_register
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2015-03-27
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Medical Devices; Neurological Devices; Classification of the Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Rules and Regulations
D09002ee1c1773ff0
D09002ee1c1774090
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
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.
80 FR 16266
https://www.govinfo.gov/app/details/FR-2015-03-27/2015-07010
2015-07010
fr27mr15-5
4164-01-P
Docket No. FDA-2015-N-0802
https://www.govinfo.gov/app/details/FR-2015-03-27/2015-07010
https://www.govinfo.gov/content/pkg/FR-2015-03-27/html/2015-07010.htm
https://www.govinfo.gov/content/pkg/FR-2015-03-27/pdf/2015-07010.pdf
Medical Devices
Neurological Devices
4 p.
16266
16269
80 FR 16266
Code of Federal Regulations
Title 21 Part 882
21 CFR Part 882
Medical Devices; Neurological Devices; Classification of the Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid; Federal Register Vol. 80, Issue
RULE
2015-07010
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2015-03-27
Docket No. FDA-2015-N-0802
4164-01-P
2015-07010
Final order.
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.
This order is effective March 27, 2015. The classification was applicable on November 17, 2014.
Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G312, Silver Spring, MD 20993-0002, 301-796-2795, jay.gupta@fda.hhs.gov.
Medical Devices
Neurological Devices
Medical Devices; Neurological Devices:
Classification of the Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
,
jay.gupta@fda.hhs.gov
http://www.regulations.gov
Federal Register
Vol. 80, no. 59
Office of the Federal Register, National Archives and Records Administration
2015-03-27
continuing
daily
deposited
born digital
309 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-03-27
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0042-1219
0364-1406
769-004-00000-9
000582072
f:fr27mr15
https://www.govinfo.gov/app/details/FR-2015-03-27
https://www.govinfo.gov/content/pkg/FR-2015-03-27/pdf/FR-2015-03-27.pdf
https://www.govinfo.gov/content/pkg/FR-2015-03-27/xml/FR-2015-03-27.xml
fdlp
16249
16545
DGPO
2015-03-27
2023-10-12
FR-2015-03-27
machine generated
eng
FR
FR-2015-03-27
80
59