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ITA Today Promoting Responsible Sun Care and Sun Burn Prevention. Founded in 1999, the Indoor Tanning Association today represents thousands of indoor tanning manufacturers, distributors, facility owners and members from other support industries. |
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05-30-2014, 06:07 AM | #1 (permalink) |
Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56
Posts: 2,888
Rep Power: 22 | 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. |
05-30-2014, 07:31 AM | #3 (permalink) |
Join Date: Sep 6 2010 Location: georgia Age: 34
Posts: 50
Rep Power: 0 | Re: FDA Reclassification At the 10 millimeter size it'll be a label about 9 inches by 2 inches. Also it doesn't specify what color background it has to be just that it has to be legible so in theory its not going to draw the eye to the label as bad as you would think if you were to use a clear background label. |
05-30-2014, 07:52 AM | #5 (permalink) | |
Team TanTalk Join Date: Aug 12 2004 Location: ITA 2004-2013 / ASA 2013
Posts: 3,444
Rep Power: 30 | Re: FDA Reclassification Quote:
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