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HHS/FDA

RIN: 0910-AH14

Publication ID: Fall 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: Section 3(f)(1) 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	03/00/2024

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 75, Room 7613, Silver Spring, MD 20993 Phone:301 796-3350 Email: daniel.schieffer@fda.hhs.gov