The ITA hosted an Open Board Meeting in Washington, D.C. on May 21, in 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 timely basis. First, in proposing that sunlamp products be regulated as Class II devices, FDA would require 510(k) pre-market 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 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 one-year grace period to secure 510(k) for equipment already in use, but leaves unanswered what would happen to discontinued product lines or beds produced by manufacturers that 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), a representative of which spoke in an advocacy role for the order. In addition, the FDA spokesman repeatedly said that this is “just the beginning.”
On August 7, the ITA will submit a detailed response to the FDA 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 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 21 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.
