The Panel Is Unanimous: Raise Tanning Beds to Higher Medical Device Classification

The US Food and Drug Administration (FDA) classifies tanning machines as Class I medical devices, meaning they are subject to few federal regulations and little oversight. However, this could soon be changing. On March 25, the General and Plastic Surgery Devices Panel of the Food and Drug Administration (FDA)’s Medical Devices Advisory Commit- tee unanimously recommended that the FDA upgrade its classification of tanning devices.

The recommendation followed four hours of testimony from the public, including physician members of The Skin Cancer Foundation and skin cancer survivors. The Panel unanimously concluded that Class I was inappropriate, since it incorrectly treats tanning machines as devices that “present minimal potential for harm to the user.” (Elastic bandages and tongue depressors are also Class I devices.) Some Panel members favored Class II, and others Class III, the most strictly regulated category. The majority of the Panel favored an age restriction to limit minors’ access. The Panel also approved of more disclosure to users about tanning’s dangers, and better placement of labels warning users about these risks.

Finally, Panel members floated the possibility of creating a registry of tanning bed users; stricter educational, testing, and recertification requirements for tanning salon staff, and ensuring that tanning bed customers read and accept health warnings prior to using a tanning machine. The FDA will now consider the Panel’s recommendations.

Published on June 7, 2010