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Old 07-18-2013, 10:52 AM   #1 (permalink)
 
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FDA Proposal Should be a sticky

URGENT
FDA Public Comment Submissions due by August 7th, 2013
Regarding FDA Proposed Reclassification

Greetings!

You may have heard that the FDA issued an Administrative Order reclassifying ultraviolet lamps for tanning to a class II medical device. If this order is approved, it could have a significant negative impact on your business. In an attempt to impact the FDA's decision, we have the opportunity to submit comments. We ask that you please submit comments to the FDA opposing the reclassification .

For your ease, we have attached the Indoor Tanning Associations stock letter, which you can copy and paste into the comments box. You must also include your organizations name, which you enter on the left side of the screen.

If you would like us to make the submission for your company, please let us know.

Instructions.
Click on the following link http://www.regulations.gov/#!submitC...13-N-0461-0001
1. Select Device Industry/ C0012 when it asks for category or the right people will not get this!!!!!!

2. Copy the message below and paste it into the comments box.

3. Enter your organization's name (on the left side of the screen).

4. Click Submit.


Docket No. FDA-2013-N-0461

As a sunbed salon owner, my business will be harmed by the unintended consequences of FDA's proposed order to re-classify tanning equipment as Class 2 medical devices and amend warning labels to include a statement about minors.

(1) The proposed order provides that products already in the marketplace must cease being used if the manufacturer does not submit a 510(k) within one year of the order's effective date. This is simply not possible, as many equipment manufacturers are no longer in business. (2) It will be cost-prohibitive for manufacturers still in business to retroactively file a 510(k), and many won't. That will make it mandatory for sunbed salons to replace much or all of their equipment at elevated prices, forcing many to close.

Closing salons is the written lobbying goal of the AAD, which FDA partnered with to announce this order in its May 6 press conference. FDA's 2010 Plastic Surgery Advisory Panel included 9 AAD members (6 dermatologists and 3 plastic surgeons) - a conflict of interest since dermatology stands to gain financially from measures that close or restrict tanning salons. Dermatology condones its own usage of sunbeds competitively to tanning salons and has lobbied to expand that "safe" service. No panel member declared that conflict, despite being asked.

That conflict of interest appears to have tainted analysis of the data supplied to FDA. Data in the WHO IARC report implicate dermatology sunbeds (96%) as the major source of risk increase for under-35 users, but showed that commercial salons did not increase risk significantly (6%).

Neither the science behind nor the effects of this order have been properly considered. FDA should revisit this issue in constructive cooperation with the sunbed market and qualified independent epidemiologists - using the working group stakeholder meeting format it convened Feb. 7-8, 2002 -- before proceeding with any rule revision.
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Old 07-18-2013, 11:15 AM   #2 (permalink)
 
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Re: FDA Proposal Should be a sticky

Is there a link for our customers that we could post on our websites/facebook?!
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