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2014-05-16
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Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravascular Administration Set, Automated Air Removal System
Rules and Regulations
D09002ee1bdc4497d
D09002ee1bdc44a83
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
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is classifying the intravascular administration set, automated air removal system 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 intravascular administration set, automated air removal system'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.
79 FR 28404
https://www.govinfo.gov/app/details/FR-2014-05-16/2014-11174
2014-11174
fr16my14-4
4160-01-P
Docket No. FDA-2014-N-0438
https://www.govinfo.gov/app/details/FR-2014-05-16/2014-11174
https://www.govinfo.gov/content/pkg/FR-2014-05-16/html/2014-11174.htm
https://www.govinfo.gov/content/pkg/FR-2014-05-16/pdf/2014-11174.pdf
Medical Devices
4 p.
28404
28407
79 FR 28404
Code of Federal Regulations
Title 21 Part 880
21 CFR Part 880
Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravascular Administration Set, Automated Air Removal System; Federal Register Vol. 79, Issue
RULE
2014-11174
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-06-16
Docket No. FDA-2014-N-0438
4160-01-P
2014-11174
Final order.
The Food and Drug Administration (FDA) is classifying the intravascular administration set, automated air removal system 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 intravascular administration set, automated air removal system'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 June 16, 2014. The classification was effective on March 4, 2014.
Alan Stevens, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 2561, Silver Spring, MD 20993-0002, 301-796-6294.
Medical Devices
Medical Devices:
Classification of the Intravascular Administration Set, Automated Air Removal System
,
http://www.regulations.gov
Federal Register
Vol. 79, no. 95
Office of the Federal Register, National Archives and Records Administration
2014-05-16
continuing
daily
deposited
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222 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2014-05-16
P0b002ee188f55480
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr16my14
https://www.govinfo.gov/app/details/FR-2014-05-16
https://www.govinfo.gov/content/pkg/FR-2014-05-16/pdf/FR-2014-05-16.pdf
https://www.govinfo.gov/content/pkg/FR-2014-05-16/xml/FR-2014-05-16.xml
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DGPO
2014-05-16
2023-04-29
FR-2014-05-16
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eng
FR
FR-2014-05-16
79
95