RIN Data

HHS/FDA RIN: 0910-AH14 Publication ID: Fall 2016 
Title: 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.

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
Action Date FR Cite
NPRM  12/22/2015  80 FR 79493   
NPRM Comment Period End  03/21/2016 
Final Action  02/00/2017 
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:
Ian Ostermiller
Regulatory Counsel, Center for Devices and Radiological Health
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66, Room 5454,
Silver Spring, MD 20993
Phone:301 796-5678
Email: ian.ostermiller@fda.hhs.gov