Regulatory Counsel

0910-AH14 202304 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: Restricted Sale, Distribution, and Use of Sunlamp Products

This rule will apply device restrictions to sunlamp products. Sunlamp products include ultraviolet (UV) lamps and UV tanning beds and booths. 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 use of sunlamp products at young ages, as well as frequently using sunlamp products, both increases 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.

]]> 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 Rule 12/00/2023 Yes Businesses State Yes No Yes No 0910-AG30 Related to Daniel Schieffer Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3350 daniel.schieffer@fda.hhs.gov Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Silver Spring MD 20993