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HHS/FDA RIN: 0910-AH14 Publication ID: Spring 2023 
Title: General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products 
Abstract:

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. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 878.4635   
Legal Authority: 21 U.S.C. 360j(e)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/22/2015  80 FR 79493   
NPRM Comment Period End  03/21/2016 
Final Rule  12/00/2023 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Related RINs: Related to 0910-AG30 
Agency Contact:
Daniel Schieffer
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66,
Silver Spring, MD 20993
Phone:301 796-3350
Email: daniel.schieffer@fda.hhs.gov