{"abstract":"The Food and Drug Administration (FDA or the Agency) is reclassifying 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 renaming them sunlamp products and UV lamps intended for use in sunlamp products. FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.","action":"Final Order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/06/02/2014-12546.html","cfr_references":[{"chapter":null,"citation_url":null,"part":878,"title":21}],"citation":"79 FR 31205","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective September 2, 2014. See further discussion in section V \"Implementation Strategy\" for compliance dates.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0461"],"dockets":[],"document_number":"2014-12546","effective_on":"2014-09-02","end_page":31214,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/06/02/2014-12546.xml","html_url":"https://www.federalregister.gov/documents/2014/06/02/2014-12546/general-and-plastic-surgery-devices-reclassification-of-ultraviolet-lamps-for-tanning-henceforth-to","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-12546?publication_date=2014-06-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-06-02/2014-12546/mods.xml","not_received_for_publication":null,"page_length":10,"page_views":{"count":6254,"last_updated":"2026-07-27 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-06-02/pdf/2014-12546.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-12546.pdf?1401376629","publication_date":"2014-06-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/06/02/2014-12546.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference16  Gallagher, R.P., J.J. Spinelli, and T.K. Lee, \"Tanning Beds, Sunlamps, and Risk of Cutaneous Malignant Melanoma,\" Cancer Epidemiology, Biomarkers & Prevention, vol. 14(3), pp. 562?566, 2005.","document_id":"FDA-2013-N-0461-1612"},{"title":"Reference13 \"IARC Working Group on Artificial Ultraviolet Light (UV) and Skin Cancer: The Association of Use of Sunbeds With Cutaneous Malignant Melanoma and Other Skin Cancers: A Systematic Review,\" International Journal of Cancer, vol. 120, pp. 1116?112","document_id":"FDA-2013-N-0461-1611"},{"title":"Reference 22 Mayer, J.A., S.I. Woodruff, D.J. Slymen, et al., \"Adolescents' Use of Indoor Tanning: A Large?Scale Evaluation of Psychosocial, Environmental, and Policy?Level Correlates,\" American Journal of Public Health, vol. 101(5), pp. 930?938, 2011","document_id":"FDA-2013-N-0461-1610"},{"title":"Reference 21 Zhang, M., A.A. Qureshi, A.C. Geller, et al., \"Use of Tanning Beds and Incidence of Skin Cancer,\" Journal of Clinical Oncology, vol. 30, pp. 1588-1593, 2012","document_id":"FDA-2013-N-0461-1609"},{"title":"Reference 20 Grant, W.B., \"Critique of the International Agency for Research on Cancer's Meta?Analyses of the Association of Sunbed Use With Risk of Cutaneous Malignant Melanoma,\" Dermatoendocrinology, vol. 1(6), pp. 294–299, 2009","document_id":"FDA-2013-N-0461-1608"},{"title":"Reference 19 Differential Risk of Malignant Melanoma by Sunbed Exposure Type","document_id":"FDA-2013-N-0461-1607"},{"title":"Reference 18  Doré, J. and M.C. Chignol, \"Tanning Salons and Skin Cancer,\" Photochemical & Photobiological Sciences, vol. 11(1), pp. 30?37, 2012","document_id":"FDA-2013-N-0461-1606"},{"title":"Reference 17 Boniol, M., P. Autier, P. Boyle, et al., \"Cutaneous Melanoma Attributable to Sunbed Use: Systematic Review and Meta?Analysis,\" British Medical Journal, vol. 345, p. e4757 July 24, 2012","document_id":"FDA-2013-N-0461-1605"},{"title":"Reference15 SEER Cancer Statistics Review 1975?2010","document_id":"FDA-2013-N-0461-1604"},{"title":"Reference 14 SEER Stat Fact Sheets: Melanoma of the Skin","document_id":"FDA-2013-N-0461-1603"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0461","supporting_documents_count":23,"docket_id":"FDA-2013-N-0461","regulation_id_number":null,"title":"General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth to be Known as Sunlamp Products","checked_regulationsdotgov_at":"2014-06-22T06:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31205,"subtype":null,"title":"General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products","toc_doc":"Reclassification of Ultraviolet Lamps for Tanning","toc_subject":"General and Plastic Surgery Devices:","topics":["Medical devices"],"type":"Rule","volume":79}