Regulatory Counsel, Center for Devices and Radiological Health

0910-AH14 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS General and Plastic Surgery Devices: Sunlamp Products

This rule would apply device restrictions to sunlamp products. The incidence of skin cancer, including melanoma, has been increasing, and a large number of skin cancer cases are attributable to the use of sunlamp products. The devices may cause about 400,000 cases of skin cancer per year, and 6,000 of which are melanoma. Beginning sunlamp product use at young ages, as well as frequently using sunlamp products, both increase the risk of developing skin cancers and other illnesses, and sustaining other injuries. Even infrequent use, particularly at younger ages, can significantly increase these risks.

Sunlamp products incorporate ultraviolet (UV) lamps and include devices such as UV tanning beds and booths. People who use sunlamp products are at increased risk of developing skin cancer and other illnesses, and sustaining injuries.

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes No 21 CFR 878.4635 21 U.S.C. 360j(e) No NPRM 12/22/2015 80 FR 79493 NPRM Comment Period End 03/21/2016 Final Action 02/00/2017 Yes Businesses State Yes No Yes No 0910-AG30 Related to Ian Ostermiller Regulatory Counsel, Center for Devices and Radiological Health 0910 Food and Drug Administration FDA 301 796-5678 ian.ostermiller@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring MD 20993