On May 6, 2013, FDA issued a proposed order to reclassify ultraviolet (UV) lamps intended for tanning from class I devices (general controls) exempt from premarket notification to class II devices (special controls) subject to premarket notification. FDA also proposed to change the focus of the classification regulation from “ultraviolet lamps” to “sunlamp products,” including not only UV lamps but also tanning beds and tanning booths.
As we have mentioned before (see here and here), and discussed in a client alert last summer (see pgs. 12-13), in July 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) made significant amendments to FDA’s device reclassification procedures. Pre-FDASIA, the process for reclassifying devices required notice-and-comment rulemaking under section 513(e) of the Federal Food, Drug, and Cosmetic Act (FDCA). Because of the administrative burden this process placed on FDA, however, relatively few devices were reclassified under these procedures. FDASIA § 608 relaxed this requirement, amending section 513(e) to allow FDA to reclassify a device through an administrative order rather than by promulgating a regulation.
FDA’s proposed order on sunlamp products, which the Agency proposed on its own initiative, offers some insight into what device companies might see in future device up-classification proposed orders.
First, in proposing that sunlamp products be regulated as class II devices, FDA proposed a very specific list of special controls that would be incorporated into the text of the regulation. For example, these special controls would require:
- 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;
- Electromagnetic compatibility testing;
- Mechanical safety;
- Software verification, validation, and hazard analysis;
- Validated cleaning instructions;
- Labeling that includes the statement: “Attention: This sunlamp product should not be used on persons under the age of 18 years”; and
- Contraindication and warning statements by sunlamp product manufacturers in user instructions, catalogs, specification sheets, descriptive brochures, and consumer-directed webpages.
This detailed list of testing and labeling requirements, including contraindications, suggests that special controls proposed by FDA in reclassification orders could be specific, numerous, and burdensome, and be incorporated into the text of a regulation rather than described in a guidance document.
Second, in this proceeding, FDA relied on pre-FDASIA advisory panel meetings, rather than conducting a new meeting to consider the Agency’s proposed order for device reclassification. Pursuant to section 513(e) as amended by FDASIA, FDA can reclassify “by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel . . ., and consideration of comments to a public docket.” The statutory language suggests that these activities would occur in the specified chronological order. But based on the sunlamp products proposed order—where the panel meetings involving recommendations regarding the classification of UV lamps were held in 1977 and 2010—it appears that FDA believes pre-FDASIA panels are sufficient for this purpose, and that a panel meeting does not need to follow publication of a proposed order in the Federal Register. This interpretation could provide less procedural protection to manufacturers than they, or Congress, had envisioned.
Finally, FDA explained in the Federal Register notice that predicate devices did exist and could be cited as predicates by manufacturers who would need to submit a 510(k) notification should the proposed order become final. FDA discussed several 510(k)s for sunlamp products that the Agency cleared before a 1994 final rule exempted these devices from premarket notification, and a 510(k) clearance for a sunlamp product under product code LEJ that occurred after the exemption went into effect. FDA indicated that these cleared devices could serve as predicates for substantial equivalence purposes. Thus, in future proposed orders to reclassify from class I to class II (or from class II exempt to class II non-exempt), FDA might include information on what predicate devices are available for 510(k) submissions.