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2015-11-20
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Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device
Rules and Regulations
D09002ee1c18929e3
D09002ee1c1892a65
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device 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 UV radiation chamber disinfection device 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 72587
https://www.govinfo.gov/app/details/FR-2015-11-20/2015-29660
2015-29660
fr20no15-12
4164-01-P
Docket No. FDA-2015-N-3838
https://www.govinfo.gov/app/details/FR-2015-11-20/2015-29660
https://www.govinfo.gov/content/pkg/FR-2015-11-20/html/2015-29660.htm
https://www.govinfo.gov/content/pkg/FR-2015-11-20/pdf/2015-29660.pdf
Medical Devices
3 p.
72587
72589
80 FR 72587
Code of Federal Regulations
Title 21 Part 880
21 CFR Part 880
Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device; Federal Register Vol. 80, Issue
RULE
2015-29660
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2015-11-20
Docket No. FDA-2015-N-3838
4164-01-P
2015-29660
Final order.
The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device 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 UV radiation chamber disinfection device 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 November 20, 2015. The classification was applicable on December 20, 2011.
Elizabeth Claverie, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2508, Silver Spring, MD 20993-0002, 301- 796-6298.
Medical Devices
Medical Devices; General Hospital and Personal Use Devices:
Classification of the Ultraviolet Radiation Chamber Disinfection Device
,
http://www.regulations.gov
Federal Register
Vol. 80, no. 224
Office of the Federal Register, National Archives and Records Administration
2015-11-20
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353 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-11-20
P0b002ee18df8b690
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr20no15
https://www.govinfo.gov/app/details/FR-2015-11-20
https://www.govinfo.gov/content/pkg/FR-2015-11-20/pdf/FR-2015-11-20.pdf
https://www.govinfo.gov/content/pkg/FR-2015-11-20/xml/FR-2015-11-20.xml
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DGPO
2015-11-20
2023-10-19
FR-2015-11-20
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FR
FR-2015-11-20
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