|06-04-2013, 07:47 PM||#1 (permalink)|
Join Date: Aug 27 2002
Location: East Coast
Rep Power: 15
ITA Update 6/4/13
Indoor Tanning Association, Inc., 2025 M St, NW Suite 800 Washington, DC 20036 · Phone: 888-377-0477 · Fax: 202-367-2142
Member Update 06/04/2013:
ITA Board Meeting Focuses on FDA Administrative Order
The ITA hosted an open board meeting in Washington, DC on May 21stin conjunction with the semiannual day on Capitol Hill. Needless to say, the top item on the agenda was discussion of the FDA's Administrative Order reclassifying ultraviolet lamps for tanning to a class II medical device.
The order was issued under a new procedure created by Congress in 2012 to expedite FDA's ability to down class medical devices and thereby make them available on a more timely basis. First, in proposing that sunlamp products be regulated as class II devices, FDA would require 510(k) premarket notifications for sunbed products, a potentially costly and lengthy process. In addition the order would add a very specific list of burdensome special controls that were never before required. The special controls would add performance testing that demonstrates: (1) the sunlamp products meet appropriate output performance specifications (e.g., wavelengths, energy density, and lamp life); and (2) safety features (e.g., timers and alarms) function properly; biocompatibility testing; and electromagnetic compatibility testing.
Although the agency did not try to ban teen tanning, they are proposing another label which would include the statement "Attention: This sunlamp product should not be used on persons under the age of 18 years” (FDA calls this a contraindication). In addition, the order would require a contraindication and warning statements by sunlamp product manufacturers in user instructions, catalogs, specification sheets, descriptive brochures, and consumer-directed webpages.
While there are numerous challenges contained in the proposed order, there are many other issues the FDA did not address and that were possibly not even contemplated by the FDA. For example, the proposed order would give manufacturers a year grace period to secure 510(k)s for equipment already in use but leaves unanswered what would happen to discontinued bed lines or beds produced by manufacturers who are no longer in business.
Perhaps the most troubling aspect of the order came at the FDA press conference. In announcing the proposed order, the Agency included a non-governmental stakeholder (American Academy of Dermatology) who spoke in an advocacy role for the order. In addition, the FDA spokesman repeatedly said that this is just the beginning.
The ITA will submit a detailed response to the FDA on August 7th and while all of the elements of the response are not final, the board has agreed that several issues must be addressed. First, there will be a vigorous challenge to the scientific justification the FDA used for the order based on the fact that the agency never responded to the detailed scientific paper the ITA submitted in 2010.
Second, because the new procedure used by the FDA takes away some of the protections that are in the more formal rulemaking process (such as, requirement for an economic impact analysis, requirement for review by the Office of Management and Budget, requirement that each comment be addressed publicly before the final rule is issued), the ITA will ask the FDA to justify why it did not follow the all of the steps and safeguards that are afforded to industry and mandated by Congress in the new procedure.
Clearly, because FDA regulates medical devices, the proposed order would have its most immediate impact on equipment manufacturers. However, the fallout and costs will affect the industry as a whole. The timing of the May 21st board meeting provided an excellent forum for the board and its advisors to hear the concerns of all segments of the industry and incorporate those concerns into the framework of our detailed response.
Join the Cause!
ITA Prepares Response to FDA
By John P. Ribner
The Indoor Tanning Association has a plan to fight the biggest battle this industry has ever faced. The only question is, are you ready to help?
The ITA is preparing its response to the Food and Drug Administration regarding proposed tanning equipment reclassification– 510(k) – announced May 6. If passed, this would have far-reaching impact upon the industry, which is why the ITA is urging everyone to get involved. "The FDA's proposal is open for public comment for 90 days,” said John Overstreet, ITA Executive Director. "After that, the agency will review all comments before final recommendations are issued. We know that the number of comments matters because the FDA has said as much, so we encourage everyone to get involved. Business owners needing assistance are urged to contact us and we will walk them through the process.”
Among the concerns raised in the ITA's response is the cost that 510(k) will pose to tanning equipment manufacturers. "The FDA would require a substantial amount of pre-market testing, and it would be very expensive for manufacturers to comply with the testing and submission requirements,” Overstreet said. "These costs would also likely be pushed down to the tanning salons, which are small businesses located throughout the country. In addition, the requirement for FDA review of a 510(k) would be especially burdensome for companies that have no experience with the medical device pre-market review process, and would likely lead to substantial delays in introducing new products to the market.”
The ITA is concerned about the length of time for approval involved in the 510(k) process. "The proposed order gives manufacturers just one year to get products approved, and there is great concern that this is insufficient,” Overstreet said. "We're also concerned about replacement lamps, as the proposed order is not clear regarding how sunlamps will be approved for replacement. Also, who is responsible for approval and labeling of equipment already in service, and discontinued equipment and sunlamps? These are questions that need to be addressed by the FDA.”
On May 6, the FDA announced its intention to reclassify tanning equipment and sunlamps to Class II medical devices. If the order is finalized, manufacturers would have to submit to the FDA a pre-market notification (510(k)) for these products, which are currently exempt from any pre-market review. Manufacturers would have to show that their products have met certain performance-testing requirements, address certain product-design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use.
As the ITA continues to prepare its response to the FDA, the organization encourages members of every tanning industry sector to register their concerns to the FDA. To help prepare for the biggest battle this industry has ever faced, contact the organization – your industry organization – and ask how you can help.
Superior UV Technologies
(888) 526-7712 x77
|06-05-2013, 07:37 AM||#2 (permalink)|
Join Date: Mar 18 2005
Rep Power: 13
Re: ITA Update 6/4/13
It looks like is not only the 501c3 and 501c4 applicants that are being "targeted " by our current administration and the runaway big government agencies that they preside over. Add the FDA to the list of government "hit squads" departments doing the political bidding of this government and their donors (Academy of Dermatology).
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