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FDA to Require Warnings on Sunlamp Products

Monday, June 02, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration issued May 29 a final order reclassifying sunlamp products and ultraviolet lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices because the UV radiation they emit may cause skin cancer. This order sets forth the following requirements.

- sunlamp products (which include tanning beds and tanning booths) must carry a visible black-box warning on the device that explicitly states that they should not be used on persons under the age of 18 years

- certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements and contraindications, including “persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer”

- manufacturers must submit a premarket notification (a 510(k)) and obtain FDA clearance prior to marketing these devices, which until now were exempt from premarket review

- manufacturers will have to show that their products meet certain performance testing requirements and address certain product design characteristics

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