United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-05-09 article Proposed Rules D09002ee1c7fb84e3 D09002ee1c7fb856b United States Department of Health and Human Services originator 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 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 Vol. 78, no. 90 Office of the Federal Register, National Archives and Records Administration 2013-05-09 continuing daily deposited born digital 312 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-05-09 P0b002ee184a3c047 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr09my13 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 fdlp 27001 27302 DGPO 2013-05-09 2024-06-03 FR-2013-05-09 machine generated eng FR FR-2013-05-09 78 90