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Old 05-30-2014, 06:07 AM   #1 (permalink)
Robert K
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Join Date: Aug 27 2002
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FDA Reclassification

By now you’ve probably heard that the Food and Drug Administration reclassified sunlamps and sunlamp products to Class II medical devices. While members of the Indoor Tanning Association are reviewing the extensive document, here’s what you need to know now:
• The order requires that sunlamp products carry a visible warning on the device advocating that the product should not be used by persons under the age of 18 years. This is called a contraindication and is NOT a ban, just a recommendation.
• The new warning label must be printed with letters 10 centimeters high, appear in a black box and read: “Attention: This sunlamp product should not be used on persons under the age of 18 years.” In addition, certain marketing materials (websites, brochures and user instructions) for sunlamp products and UV lamps must now include additional and specific warning statements and other warnings.
• Manufacturers of sunlamp products must now submit a premarket notification (also called a “510(k)”) to the FDA – and obtain FDA clearance – prior to marketing new products. For products already being sold, the manufacturer has 450 days from June 2 to submit the 510(k). For equipment already in stores, there is a 450-day grace period beginning June 2 for relabeling with the new warning. (Salon owners are responsible for relabeling existing equipment, working in concert with the manufacturer.)
The ITA expects to have a more detailed analysis and recommendations on how to comply with this ruling next week.
Robert Klem
Superior UV Technologies
(888) 526-7712 x77
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