FDA Tightens Controls on UV Tanning 'Sunlamps'
The Food and Drug Administration is tightening controls on ultraviolet tanning lamps, reclassifying the devices from class I into class II and requiring a special "black box" warning. The reclassification makes the tanning lamps subject to premarket notification requirements, and imposes special controls that FDA deemed necessary for safe use. The final order also renames the devices "sunlamp products," but includes language that clarifies the requirements apply to both sunlamp products and UV lamps intended for use in sunlamp products.
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The black box warning must say that the sunlamp product should not be used on persons under the age of 18 years. The order also requires that certain marketing materials promoting sunlamp products and UV lamps carry additional warnings and contraindications, including “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
The reclassification of sunlamps into class II means manufacturers and importers will have to submit a premarket notification (510(k)) to FDA and obtain clearance before marketing these devices. Manufacturers and importers also will now have to show that their products meet certain performance testing requirements and address certain product design characteristics, said FDA.
An FDA press release on the reclassification is available (here).
(Federal Register 06/02/14)