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Old 06-01-2014, 08:54 AM   #1 (permalink)
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Exclamation FDA Reclassification Summary

________________________________________

May 30, 2014

Regulatory Update – Reclassification Order for Sunlamps and Sunbeds

The outline below is a more detailed analysis of the reclassification order that will be published in the Federal Register on Monday June 2, 2014. That date is important because it starts the clock on the 90 day and 450 day compliance requirements in the order.

• FDA has reclassified sunlamp products (tanning beds and booths), and UV lamps intended for use in sunlamp products, from class I to class II medical devices.

• This reclassification means that sunlamp products and UV lamps intended for use in sunlamp products:
o Are subject to the 510(k) premarket notification requirements (subject to certain compliance dates described below):
• A 510(k) can be submitted for a sunlamp product plus UV lamp intended for use with that product;
• UV lamps will require a 510(k), but the manufacturer might be able to submit one “bundled” 510(k) for related lamps (in accordance with an FDA guidance document on bundling multiple devices in a single submission) and one 510(k) for a replacement lamp that can be used in multiple tanning beds/booths;
• The “predicate device” for sunlamp products and lamps can be a product that has a 510(k) clearance or “any 510(k)-exempt sunlamp product or UV lamp legally offered for sale on or before” the effective date of the order (which is 90 days from the date it is published in the Federal Register, expected to be Monday, June 2);

o Must conform to the established Special Controls for these devices, which include testing and labeling requirements;
o Testing requirements include the following, and the test data must be included in the 510(k)s:
• Performance testing on output performance specifications (such as wavelengths and energy intensity) and on proper functioning of safety features (such as timers to limit UV exposure times);
• Mechanical safety to prevent user injury;
• Software verification, validation, and hazard analysis (applicable to beds and booths, but not likely to UV lamps only);
• Biocompatibility (with respect to device parts that touch the human body);
• Electrical safety, and electromagnetic compatibility for the environment in which the product will be used;

o Labeling requirements include the following:

• Labeling requirements applicable to only sunlamp products:
• The black box warning “Attention: This sunlamp product should not be used on persons under the age of 18 years” must appear on all sunlamp products, consistent with the size and location requirements established by the order.
• Manufacturers must include validated instructions on cleaning and disinfecting sunlamp products between uses in their user instructions.

• Labeling requirements applicable to both sunlamp products and UV lamps intended for use in sunlamps:
• All user instructions, as well as consumer directed catalogs, specification sheets, descriptive brochures, and webpages in which these devices are offered for sale must contain these warning/contraindication statements:
• “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
• “Contraindication: This product must not be used if skin lesions or open wounds are present.”
• “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
• “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”

• The effective date of the final order will be 90 days after publication of the order in the Federal Register.

• Compliance periods:
• Models of sunlamp products and UV lamps intended for use in sunlamp products (or significant changes or modifications to these models) that have not been offered for sale before the effective date of the final order, must obtain 510(k) clearance before the new or changed model may be marketed.

• For models of sunlamp products and UV lamps intended for use in sunlamp products that are offered for sale before the effective date of the final order and continue to be offered for sale after the effective date of the final order, a manufacturer must submit a 510(k) and comply with the labeling special controls by 450 days after publication of the final order in the federal register.
• If a manufacturer does not submit the required 510(k) within the 450 days following publication of the order, or the labeling special controls for a device are not followed within 450 days following publication of the order, or FDA does not clear a filed 510(k) premarket notification (i.e., the agency issues a not substantially equivalent (NSE) order), then the device at issue is considered adulterated and misbranded and can no longer be lawfully held for sale.

• If a sunlamp product or UV lamp has been shipped to operators/users/individual consumers before the effective date of the final order and the model has been discontinued or is otherwise no longer offered for sale, the device must still comply with the labeling special controls within 450 days of the effective date of the final order.
• 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.

From the ITA
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Old 06-01-2014, 11:11 PM   #2 (permalink)
 
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Re: FDA Reclassification Summary

Layman term.....
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Old 06-03-2014, 08:27 AM   #3 (permalink)
 
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Re: FDA Reclassification Summary

Click on the link below to access the document "General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp
Products and Ultraviolet Lamps Intended for Use in Sunlamp Products."

Read it and weep!

Comments to follow after I have had time to "digest" the data.


http://www.gpo.gov/fdsys/pkg/FR-2013...2013-10982.htm
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Old 06-03-2014, 12:19 PM   #4 (permalink)
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Re: FDA Reclassification Summary

All I can say is "Thank God I'm at the end, and not the beginning of my tanning business career.
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Old 06-03-2014, 10:19 PM   #5 (permalink)
 
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Re: FDA Reclassification Summary

Suncity, I guess in laymen's terms it would be:

-The FDA has pretty much taken it out of each state's hands regarding under 18 bans and are requiring black box warning labels and contraindications listed on all of our equipment within 1 year and will be actively enforcing it. It becomes federal now (across the board).

-They used a bunch of bogus studies stating tanning beds do cause cancer and that there is no proof that they generate Vitamin D, or even provide protection against burning. Using these so called studies they decided that our equipment be upgraded from a Class I to a class II medical/plastic surgery device which is essentially the gateway to Derms/Medical being the only ones able to provide services with tanning equipment. IMHO.
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Old 06-03-2014, 10:51 PM   #6 (permalink)
 
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Re: FDA Reclassification Summary

If you are under 18 you have to a parent note and they had to be there with you or an adult, that 18 +,So a tanning bed is a tanning bed so were is it going be listed as class II device, seem to me it just a label to be added to you old unit.
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Old 06-04-2014, 04:27 AM   #7 (permalink)
 
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Re: FDA Reclassification Summary

Yes, for now. I'm just looking @ the bigger picture. The camel has gotten it's nose under the tent, so to speak.
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Old 06-04-2014, 09:19 AM   #8 (permalink)
 
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Re: FDA Reclassification Summary

"Labeling requirements applicable to both sunlamp products and UV lamps intended for use in sunlamps"

What does this mean. This is as clear as mud.
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Old 06-04-2014, 12:30 PM   #9 (permalink)
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Re: FDA Reclassification Summary

Quote:
Originally Posted by sbt501 View Post
"Labeling requirements applicable to both sunlamp products and UV lamps intended for use in sunlamps"

What does this mean. This is as clear as mud.
That would mean labels on the bed and labels on each lamp in the bed.
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Old 06-05-2014, 08:19 AM   #10 (permalink)
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Re: FDA Reclassification Summary

Quote:
Originally Posted by Turbo Girl View Post
Yes, for now. I'm just looking @ the bigger picture. The camel has gotten it's nose under the tent, so to speak.
Great analysis, Turbo Girl. "A bear has gotten loose in the tent", could be more accurate when it comes to THE FIGHT we have before us. The bear is so determined to kill us all. Amen
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