The FDA 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. The order requires that sunlamp products carry a visible black-box warning that explicitly states that the sunlamp product should not be used on persons under the age of 18 years.
In addition, certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements and contraindications.
“The FDA has taken an important step today to address the risk to public health from sunlamp products,” said Jeffrey Shuren, MD, 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.”
As part of the action, manufacturers must submit a premarket notification (also called a “510(k)”) to the FDA, and obtain FDA clearance, prior to marketing these devices, which until now were exempt from premarket review. Manufacturers also will now have to show that their products meet certain performance testing requirements and address certain product design characteristics, and will have to include certain warnings and contraindications on sunlamp products and in certain marketing materials for sunlamp products and UV lamps that present consumers with clear information on the risks of use.
In addition to a warning placed on the sunlamp, certain marketing materials promoting sunlamp products and UV lamps must carry additional warnings and contraindications, including “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
More info: www.fda.gov