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Old 06-25-2014, 09:27 AM   #21 (permalink)
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Re: FDA Reclassification Summary

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Distributors and manufactures will have them available in the next few months. We have about a year to comply.
Hopefully these labels will be made to be fairly easy to remove and replaced.
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Old 06-25-2014, 11:24 AM   #22 (permalink)
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Re: FDA Reclassification Summary

Is the FDA "spy in the sky" going to monitor who affixes them to each bed? Wonder what the fine will be for not having them on.
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Old 06-25-2014, 01:20 PM   #23 (permalink)
 
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Re: FDA Reclassification Summary

I'm confused on the lamps. Robert can you clarify what the changes on them will be if any?
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Old 06-25-2014, 02:38 PM   #24 (permalink)
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Re: FDA Reclassification Summary

Lamps will have to have some additional warnings included on the user sheets. We have a few questions pending with the FDA and once they are clarified I will list all the relevant information here.
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Old 06-25-2014, 02:43 PM   #25 (permalink)
 
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Re: FDA Reclassification Summary

I was trying to figure it out myself, but there is so much double speak from the FDA that conflicts itself. So I figured it was time to ask the lamp pros.

Thanx so much!!!
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Old 07-08-2014, 11:23 PM   #26 (permalink)
 
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Re: FDA Reclassification Summary

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If the manufacturer of the device is no longer in business, then it is the responsibility of the sunlamp product owner to apply the required labeling.

Are these labels going to essentially be pretty standard and available from our distributors???

The manufacturer of much of my equipment is out of business and not otherwise available to help me with the relabeling of my equipment. Is that going to be an issue with the FDA or do I just need to label??? I won't have to do any form 510 compliance crap myself, will I???

Are lamps purchased today or hereafter which have not been labelled or approved by the FDA (according to whatever the final compliance rules require) likely to become obsolete or, more specifically, a violation once the 450 days elapses???
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Old 07-09-2014, 08:03 AM   #27 (permalink)
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Re: FDA Reclassification Summary

Labels will be readily available from most tanning companies. Lamps will have some updated info on the user sheets and that is about it. Virtually no impact at the salon level is anticipated at this point. More to come after we meet with the FDA.
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Old 07-09-2014, 08:38 AM   #28 (permalink)
 
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Re: FDA Reclassification Summary

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Yes, for now. I'm just looking @ the bigger picture. The camel has gotten it's nose under the tent, so to speak.
Yes, you can kiss under 18 tanning goodbye, nationwide. There is no way that state legislatures will vote against an FDA mandated warning label and allow 18 year olds to tan in their states.

The noose is tightening around our necks.....
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Old 07-15-2014, 10:27 PM   #29 (permalink)
 
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Re: FDA Reclassification Summary

If I read the Federal Register Correctly the following label has to be applied to the tanning bed:

Attention: This sunlamp product should not be used on persons under the age of 18 years.

The rest of labeling requirement appears to only have to appear in the brochures etc. not on the bulb itself,

(ii) Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:
(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”

Do others agree? If so this means that I have to put a sticker on my existing beds to be in compliance?
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Old 07-16-2014, 03:56 AM   #30 (permalink)
 
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Re: FDA Reclassification Summary

Tanning enemies decided that this was far more effective than waiting for states to ban tanning for minors in all 50 states. Just get the federal government to do it.
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