Our change from Class I to Class II medical devices has raised some questions recently.
Q. I was told by a South Carolina salon inspector that in the future, I would need to replace lamps in my beds with only the lamp product listed on the bed labels. I’ve heard that some bed manufacturers are saying the same thing. Is this true?
A. There is a misunderstanding on the part of both the inspector and the bed maker(s) who make this statement. Many beds/booths are in service with lamps that have been retired for years but are still listed on the equipment label. FDA’s Policy on Lamp Compatibility about replacement lamps remains in effect under the Class II conditions. FDA’s requirements stated in the reclassification order say nothing about restricting replacement to the originally installed lamp. Lamps that are listed with FDA as compatible to the lamp on the bed label may be used for replacement purposes. If you use an FDA-recognized compatible lamp, you are covered within FDA’s applicable rules. Manufacturers of tanning equipment and manufacturers of tanning lamps must file special reports for equipment and lamps that have been or are still in use. Salons have no such requirement.
Lamp and equipment manufacturers must also use four contraindication and warning statements on their products and marketing materials. Salons have only one requirement regarding new labeling, which is discussed below.
Q. Does the Class II category mean that my salon is not allowed to serve people who are under 18 years of age?
A. No, people under 18 are allowed to tan indoors, subject to state or local laws or regulations where you do business. However, according to the new FDA regulations, the warning statement shown below must appear on each tanning device in the salon:The text contained on this label must meet certain criteria and be displayed in a black outlined box as shown at the right.
To obtain compliant labels, check with the manufacturer of your equipment or the distribution company that supplies you with replacement lamps, tanning equipment or other products you use or sell at your facility.
Attention: This sunlamp product should not be used on persons under the age of 18 years.
The new requirements for Class II devices, including the application of the label shown here, must be met by August 26, 2015. ■
