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HHS/FDA | RIN: 0910-AH14 | Publication ID: Fall 2024 |
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. A large number of skin cancer cases, including cases of melanoma, are attributable to the use of sunlamp products. 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. |
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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 |
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Timetable:
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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 |