FDA Reclassification Summary - Page 4 - tanTALK

Robert K · 07-16-2014, 07:30 AM

Quote:

Originally Posted by btaylor36

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?

In short yes. You have over a year to comply and once we meet with the FDA the ITA will publish exactly when and what needs to be done. No worries at all.

DENISEandLIV · 07-31-2014, 11:00 AM

Just some food for thought. We all post lists of medications for our clients. On that list are several types of "steroids." This list is a guideline to help our clients tan responsibly. There are hundreds if not thousands of different types of steroids that are placed in the foods we eat. All regulated by the FDA. These steroids are then in our bodies as we march out into the daily sunshine. THESE are the main causes of melanoma ... and are the reason so many people contract melanoma on a yearly basis. If the FDA allows these steroids to be placed in foods ... it is contradictory for them to label our industry as the main cause of melanoma. Just sayin'

peach · 07-31-2014, 12:25 PM

Quote:

Originally Posted by DENISEandLIV

Just some food for thought. We all post lists of medications for our clients. On that list are several types of "steroids." This list is a guideline to help our clients tan responsibly. There are hundreds if not thousands of different types of steroids that are placed in the foods we eat. All regulated by the FDA. These steroids are then in our bodies as we march out into the daily sunshine. THESE are the main causes of melanoma ... and are the reason so many people contract melanoma on a yearly basis. If the FDA allows these steroids to be placed in foods ... it is contradictory for them to label our industry as the main cause of melanoma. Just sayin'

All of their "information" or lack there of is either directly or indirectly leading to more cancers of every kind. They use indoor tanning as a scapegoat.

Eddyo · 10-21-2014, 12:10 PM

In the long run I think the new regulations will actually benefit existing tanning salons.

I can't see anyone opening up a new location or expanding after the August 26 2014 deadline.

Robert K · 10-21-2014, 02:06 PM

Why? What does the new FDA rule have to do with opening a salon?

Eddyo · 10-21-2014, 04:39 PM

First, it's going to be tough to find new equipment after the deadline (sorry... should of read August 26, 2015. As of yet I don't know of any tanning bed manufacturer that has a 510k for any of their models. Most companies won't even bother to apply. Those that do, if any, with limit their available models.

Secondly, lots more testing/certification/requirements are required for 510K & class ll medical devices. In order to pass electrical testing most units will require that their intensity be dramatically reduces which will probably be the end of High Pressure or High intensity units.

Third, higher costs/less competition will probably mean a higher price tag.

Less selection, lower output, longer session times, higher costs = doesn't sound appealing to a new salon owner.

Robert K · 10-21-2014, 05:13 PM

WRONG on everything.

All the companies that I know of are well on their way.
Ergoline
UWE
KBL
Heartland
Suncapsule
and more
These alone count for probably 90% of the units sold in the commercial arena.

The 510K process in pretty painless. No company will have to reduce their units output at all.

Please stop posting completely false and misleading information.

Eddyo · 10-22-2014, 09:57 AM

510K is anything but painless. It's complicated, time consuming and expensive. I'm not sure to whom you're talking to that's painting such a rosy picture, but ask them next time whatever happened to their Red Light units. All that was needed was an easy breezy 510k.

Besides the 510K, there's also class II requirements. Most tanning units/models available on the market today would fail on EMF testing alone.

But, then again what do I know. We'll see in a years time.

eileen · 10-22-2014, 10:58 AM

I've always heard what Eddyo is saying. Robert is the talk of a backlog for 510K's in the news not true?

Robert K · 10-22-2014, 11:19 AM

No none of it is true. NONE.

We (ITA) have met with the FDA and communicated with them on multiple occasions and expect the 510K process to be fairly painless. Each current manufacturer is expected to file one (1) 510K for all their currently marketed products only. Besides for some labeling changes and such the units do not need to be changed in anyway. It is expected to cost somewhere between 5-10K per 510K filed. They do not expect any delays with reviewing the 20 or so 510K's they will be receiving in the next year from the tanning industry.

Your analogy to the red light beds is also wrong. There are no predicate devices for the red light units. In the case of tanning beds there are. BIG difference.

Why not inform yourself before posting misleading information?

07-31-2014, 11:00 AM	#32 (permalink)
DENISEandLIV Join Date: Oct 22 2013 Location: LAS VEGAS, NV Posts: 10 Rep Power: 0	Re: FDA Reclassification Summary Just some food for thought. We all post lists of medications for our clients. On that list are several types of "steroids." This list is a guideline to help our clients tan responsibly. There are hundreds if not thousands of different types of steroids that are placed in the foods we eat. All regulated by the FDA. These steroids are then in our bodies as we march out into the daily sunshine. THESE are the main causes of melanoma ... and are the reason so many people contract melanoma on a yearly basis. If the FDA allows these steroids to be placed in foods ... it is contradictory for them to label our industry as the main cause of melanoma. Just sayin'

10-21-2014, 12:10 PM	#34 (permalink)
Eddyo Join Date: Oct 13 2006 Posts: 4 Rep Power: 0	Re: FDA Reclassification Summary In the long run I think the new regulations will actually benefit existing tanning salons. I can't see anyone opening up a new location or expanding after the August 26 2014 deadline.

10-21-2014, 02:06 PM	#35 (permalink)
Robert K Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56 Posts: 2,888 Rep Power: 22	Re: FDA Reclassification Summary Why? What does the new FDA rule have to do with opening a salon? __________________ Robert Klem Superior UV Technologies (888) 526-7712 x77 robertk@superioruv.com

10-21-2014, 04:39 PM	#36 (permalink)
Eddyo Join Date: Oct 13 2006 Posts: 4 Rep Power: 0	Re: FDA Reclassification Summary First, it's going to be tough to find new equipment after the deadline (sorry... should of read August 26, 2015. As of yet I don't know of any tanning bed manufacturer that has a 510k for any of their models. Most companies won't even bother to apply. Those that do, if any, with limit their available models. Secondly, lots more testing/certification/requirements are required for 510K & class ll medical devices. In order to pass electrical testing most units will require that their intensity be dramatically reduces which will probably be the end of High Pressure or High intensity units. Third, higher costs/less competition will probably mean a higher price tag. Less selection, lower output, longer session times, higher costs = doesn't sound appealing to a new salon owner.

10-21-2014, 05:13 PM	#37 (permalink)
Robert K Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56 Posts: 2,888 Rep Power: 22	Re: FDA Reclassification Summary WRONG on everything. All the companies that I know of are well on their way. Ergoline UWE KBL Heartland Suncapsule and more These alone count for probably 90% of the units sold in the commercial arena. The 510K process in pretty painless. No company will have to reduce their units output at all. Please stop posting completely false and misleading information. __________________ Robert Klem Superior UV Technologies (888) 526-7712 x77 robertk@superioruv.com

10-22-2014, 09:57 AM	#38 (permalink)
Eddyo Join Date: Oct 13 2006 Posts: 4 Rep Power: 0	Re: FDA Reclassification Summary 510K is anything but painless. It's complicated, time consuming and expensive. I'm not sure to whom you're talking to that's painting such a rosy picture, but ask them next time whatever happened to their Red Light units. All that was needed was an easy breezy 510k. Besides the 510K, there's also class II requirements. Most tanning units/models available on the market today would fail on EMF testing alone. But, then again what do I know. We'll see in a years time.

10-22-2014, 10:58 AM	#39 (permalink)
eileen Join Date: Feb 10 2005 Posts: 8,304 Rep Power: 35	Re: FDA Reclassification Summary I've always heard what Eddyo is saying. Robert is the talk of a backlog for 510K's in the news not true? __________________ "under exposure to UV rays is as dangerous as overexposure....this is D life" eileen

10-22-2014, 11:19 AM	#40 (permalink)
Robert K Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56 Posts: 2,888 Rep Power: 22	Re: FDA Reclassification Summary No none of it is true. NONE. We (ITA) have met with the FDA and communicated with them on multiple occasions and expect the 510K process to be fairly painless. Each current manufacturer is expected to file one (1) 510K for all their currently marketed products only. Besides for some labeling changes and such the units do not need to be changed in anyway. It is expected to cost somewhere between 5-10K per 510K filed. They do not expect any delays with reviewing the 20 or so 510K's they will be receiving in the next year from the tanning industry. Your analogy to the red light beds is also wrong. There are no predicate devices for the red light units. In the case of tanning beds there are. BIG difference. Why not inform yourself before posting misleading information? __________________ Robert Klem Superior UV Technologies (888) 526-7712 x77 robertk@superioruv.com Last edited by Robert K; 10-22-2014 at 11:29 AM.

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