General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products
fda-device · Food and Drug Administration · Rule · Published 2014-06-02 · Effective 2014-09-02 · 79 FR 31205
Document
Document number
2014-12546
Federal Register citation
79 FR 31205
CFR reference
21 CFR 878
Type
Rule
Action
Final Order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-06-02
Effective date
2014-09-02
HHS docket
Docket No. FDA-2013-N-0461
Abstract
The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and renaming them sunlamp products and UV lamps intended for use in sunlamp products. FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.