The U.S. Food and Drug Administration has issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices as they pertain to skin cancer risk.
The reclassification also requires that sunlamp products carry a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under 18. On top of that, certain marketing materials for sunlamp products and UV lamps are now required to include additional and specific warning statements and contraindications, such as "Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer."
Sunlamp products (including tanning beds and tanning booths) emit UV radiation known to be a risk factor for skin cancer. The American Academy of Dermatology says that people exposed to UV radiation from indoor tanning experience a 59 percent increase in the risk of melanoma, the deadliest type of skin cancer, and that risk increases each time they use a sunlamp product.
"The FDA has taken an important step today to address the risk to public health from sunlamp products," said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. "Repeated UV exposure from sunlamp products poses a risk of skin cancer for all users—but the highest risk for skin cancer is in young persons under the age of 18 and people with a family history of skin cancer."
Manufacturers must also submit a premarket notification (known as a 510(k)) to the FDA – and obtain FDA clearance – prior to marketing these devices. This is a substantial change from the past, in which such items were exempt from premarket review.
Manufacturers must also demonstrate that their products meet certain performance testing requirements and address certain product design characteristics.
This final order follows the recommendations from an expert panel meeting convened in March of 2010. This panel of experts outside the agency evaluated the risks of sunlamp products, and recommended that FDA increase regulation of these devices and certain members of the panel recommended that children and teenagers not use the products.
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