FDA Says Sunlamps No Longer Low-Risk
The FDA announced a final order reclassifying sunlamp products and ultraviolet (UV) lamps designed for use in sunlamp products from low-risk (Class I) to moderate-risk (Class II) devices.
This issuance follows the recommendations from an expert panel meeting that convened in March 2010. After evaluating the risks of sunlamp products, the panel recommended that the FDA increase regulation of these devices. Certain members further recommended that children and teenagers not use the products. Data from the American Academy of Dermatology showed people who have been exposed to UV radiation from indoor tanning experience a 59% increase in the risk of melanoma. This risk is said to increase each time they use a sunlamp product.
As required of the new order, sunlamp products are required to display a visible black box warning on the device that states that the sunlamp product should not be used on persons under <18 years old. Also, certain marketing materials must include additional and specific warning statements and contraindications, including “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer. Manufacturers will now have to submit a 510(k) to the FDA and obtain clearance prior to marketing these devices. Also, manufacturers will have to show that their products meet certain performance testing requirements and product design characteristics.
For more information call (888) 463-6332 or visit FDA.gov.