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2013-05-09
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General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products
Proposed Rules
D09002ee1bdca3b21
D09002ee1bdca3ba9
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 proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. FDA is also designating special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information.
78 FR 27117
https://www.govinfo.gov/app/details/FR-2013-05-09/2013-10982
2013-10982
fr09my13-29
4160-01-P
Docket No. FDA-2013-N-0461
https://www.govinfo.gov/app/details/FR-2013-05-09/2013-10982
https://www.govinfo.gov/content/pkg/FR-2013-05-09/html/2013-10982.htm
https://www.govinfo.gov/content/pkg/FR-2013-05-09/pdf/2013-10982.pdf
Medical Devices
8 p.
27117
27124
78 FR 27117
Code of Federal Regulations
Title 21 Part 878
21 CFR Part 878
General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products; Federal Register Vol. 78, Issue
PRORULE
2013-10982
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2013-08-07
Docket No. FDA-2013-N-0461
4160-01-P
2013-10982
Proposed Order.
The Food and Drug Administration (FDA) is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. FDA is also designating special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information.
Submit either electronic or written comments on this proposed order by August 7, 2013. See section XI for the proposed effective date of a final order based on this proposed order.
Neil R.P. Ogden, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 1438, Silver Spring, MD 20993-0002, 301- 796-6397.
Medical Devices
General and Plastic Surgery Devices:
Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products
,
http://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm205684.htm
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM205687.pdf
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm
http://www.ncsl.org/issues-research/health/indoor-tanning-restrictions.aspx
http://www.regulations.gov
http://www.who.int/mediacentre/factsheets/fs287/en/index.html
Federal Register
Vol. 78, no. 90
Office of the Federal Register, National Archives and Records Administration
2013-05-09
continuing
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Table of Contents:
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GS 4.107:
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https://www.govinfo.gov/app/details/FR-2013-05-09
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https://www.govinfo.gov/app/details/FR-2013-05-09
https://www.govinfo.gov/content/pkg/FR-2013-05-09/pdf/FR-2013-05-09.pdf
https://www.govinfo.gov/content/pkg/FR-2013-05-09/xml/FR-2013-05-09.xml
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