FDA Wants Cancer Warnings, Plans to Reclassify Tanning Beds as Class II Medical Devices

FDA Wants Cancer Warnings, Plans to Reclassify Tanning Beds as Class II Medical Devices

May 7th, 2013 // 1:17 pm @ jmpickett

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FDA today came out with a proposed order that if it is finalized, is going to reclassify tanning beds and related sunlamp products as class II medical devices, and they will require a label that will warn people under 18 to not use such products. Indoor tanning beds would have to have new labels on them disclosing a higher cancer risk. They also would be subject to much stricter FDA oversight and regulations.

FDA would want to see cancer warnings on the tanning beds, catalogs, pamphlets and on any websites that promote tanning bed use. FDA also wants to see new safety and design mandates, and this would include timers and strict limits on the amount of radiation emitted.

Note: We are holding a Webinar June 12 that will update you on this entire tanning bed issue, plus how to submit a 510(k) successfully to FDA.

FDA 510(k) Approval Would Be Required for Tanning Beds

The American Academy of Dermatology says that there is a 75% higher risk of skin cancer, or melanoma in people who have gone to indoor tanning establishments on a regular basis. The risk goes up with every use. There have been a growing number of cases of melanoma – the most serious form of skin cancer – in people in their late teens and early 20s.

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It also has been reported to FDA that children as young as 10 or 12 regularly go to tanning salons without parental knowledge or approval.

According to the FDA Commissioner Margaret Hamburg, the use of indoor tanning beds can really damage the skin and greatly increase the chances of skin cancer. FDA hopes that the proposed changes will help to reduce some risks of tanning beds.

If the FDA order is made final, all of these device manufacturers will need to provide FDA with a pre market notification 510k for such devices. Right now, tanning beds are exempt from pre market review. Device manufacturers would need to show that the products have met testing requirements, and would need to address several design characteristics of the product and give labeling that gives consumers maximum information on device risks.

FDA believes that new, class II safety standards for these devices are important. The agency claims that many of the tanning beds will burn users even when directions are followed. A study in 2010 found that almost 60% of teenagers who use the beds get sunburn from them.

For more information about obtaining a 510(k) clearance, be sure to review our upcoming Webinar on the FDA 510(k) process.

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• May 30 – The Essentials of Complaint Handling and Post Market Management – How to Comply With Global Regulatory Requirements
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