Source: https://www.federalregister.gov/articles/2013/05/09/2013-10982/general-and-plastic-surgery-devices-reclassification-of-ultraviolet-lamps-for-tanning-henceforth-to
Timestamp: 2015-08-27 21:24:31
Document Index: 328992886

Matched Legal Cases: ['art 807', 'art 807', 'arts 1000', '§ 1040', '§ 1040', '§ 1040', '§ 1040', '§ 1040', '§ 1040', '§ 807', '§ 878', '§ 878', '§ 878', '§ 878', 'art 878', '§ 878', '§ 1040']

Federal Register | General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products
Dates: Submit either electronic or written comments on this proposed order by August 7, 2013. See section XI for the proposed effective date of a final order based on this proposed order.
-27124 (8 pages)
Document Number: 2013-10982
Shorter URL: https://federalregister.gov/a/2013-10982 Related Topics
The Federal Food, Drug, and Cosmetic Act (the FD Act) establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). One type of general control provided by the FD Act is a restriction on the sale, distribution, or use of a device under section 520(e) of the FD Act (21 U.S.C. 360j(e)). A restriction under section 520(e) must be implemented through rulemaking procedures, unlike the administrative order procedures that apply to this proposed reclassification under section 513(e) of the FD Act, as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144).
Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified under section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is classified or reclassified into class I or II under section 513(f)(2) or (3) of the FD Act or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA also regulates electronic products under chapter 5, subchapter C, of the FD Act (21 U.S.C. 360hh et
seq.). Under these provisions, FDA administers an electronic product radiation control program to protect the public health and safety. This authority provides for developing, amending, and administering radiation safety performance standards for electronic products, including sunlamp products. Sunlamp products are subject to the regulations for electronic product radiation control, including 21 CFR parts 1000 through 1010 and § 1040.20 (21 CFR 1040.20). The sunlamp products performance standard in § 1040.20 was originally published in the Federal Register on November 9, 1979 (44 FR 65352). In the Federal Register of September 6, 1985 (50 FR 36548), FDA amended § 1040.20 and made it applicable to all sunlamp products manufactured on or after September 8, 1986. FDA plans to propose amendments to this performance standard to reflect current scientific knowledge related to sunlamp use, harmonize it more closely with International Electrotechnical Commission (IEC) International Standard 60335-2-27, Ed. 5.0: 2009-12, and strengthen the warning statement required by § 1040.20(d)(1)(i) in accordance with the results of the study FDA conducted under section 230 of the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85).
FDA agreed with the Panels' recommendations and proposed that these devices be classified into class II in a proposed rule published in the Federal Register on January 19, 1982. However, in its final rule, published on June 24, 1988 (53 FR 23856 at 23868), FDA separated UV lamps for dermatological disorders and UV lamps for tanning. It classified the former in class II under 21 CFR 878.4630, but postponed classification of UV lamps for tanning in order to consider electrical safety information and to consider issuing a proposal to classify UV lamps for tanning in class I. FDA explained that the performance standard for sunlamp products at § 1040.20 addressed the risks to health presented by UV lamps for tanning other than electrical safety hazards. On November 15, 1988 (53 FR 46040), FDA proposed that 70 electromedical devices, including UV lamps for tanning, be classified in class I; FDA finalized this classification on November 20, 1990 (55 FR 48436 at 48440).
On December 7, 1994, FDA amended the classification when it published a final rule in the Federal Register (59 FR 63005) that exempted 148 class I devices from premarket notification (with limitations), including UV lamps for tanning. FDA determined that manufacturers' submissions of premarket notifications for UV lamps for tanning were not necessary for the protection of the public health at that time. Prior to the issuance of the 1994 final rule exempting UV lamps for tanning from premarket notification submission, some manufacturers of UV lamps for tanning had already submitted 510(k)s and received clearance for their devices, and at least one 510(k) for a sunlamp product has been cleared since then. As discussed further in this document, these devices may serve as predicate devices for future 510(k)s if this order is finalized. On July 25, 2001, FDA made a technical amendment to the classification of UV lamps for tanning to state that the exemption from 510(k) is subject to the limitations in 21 CFR 878.9 (66 FR 38786 at 38803).
IV. Summary of Valid Scientific Evidence Concerning Reclassification Back to Top
2. Ocular Injury: UV and visible radiation from this device can be harmful to the eyes if proper protective eyewear is not worn.
3. Discomfort, Pain, and Tenderness on the Skin Resulting From Burns to the Skin due to Acute Overexposure to UV Radiation: A recent evaluation showed that, despite protective measures instituted in commercial tanning facilities, 66 percent of female college-age users reported skin erythema (or redness due to sunburn) from indoor tanning, and these users reported one episode of sunburn out of every five tanning sessions (Ref. 28). Those findings are in line with a previous report that 58 percent of adolescent tanning bed users had experienced sunburns from exposure to sunlamps (Ref. 29). In certain individuals who are photosensitive, skin exposure to UV radiation may induce unexpected reactions such as rash, severe burns, and hypersensitivity reactions (Ref. 30). Sunlamps, like most light sources, also generate heat that can cause thermal skin burns, similar to any hot surface. Individuals with open wounds or lesions are particularly susceptible to burns from UV light because those individuals lack the protective epidermal layer of the skin that provides the body's greatest protection from UV irradiation (Ref. 31).
V. 2010 Classification Panel Meeting Back to Top
Docket No. FDA-2009-N-0606 was opened to receive comments on the regulation of sunlamp products (75 FR 1395; January 11, 2010). The majority of the input received via the open public docket supported strengthening FDA's regulation of these devices. Although many comments did not expressly specify whether regulation of sunlamps should be strengthened or not, because most of these were related to the experiences of people with melanoma, FDA interpreted them to be in support of stricter regulation of sunlamps. Six comments of 139 total comments took the position that FDA should not change its current regulation of indoor tanning devices. Overall, the docket comments strongly paralleled the opinions of the Panel members.
VI. Proposed Reclassification Back to Top
The proposed special controls for this device—identified as follows (and underlined)—are necessary to provide a reasonable assurance of safety and effectiveness for this device. Failure to comply with the special controls that are included in a final order would cause a sunlamp product to fall outside this classification, and thus be classified in class III. Failure to obtain premarket approval of a class III device prior to marketing causes the device to be adulterated under section 501(f) of the FD Act (21 U.S.C. 351(f)).
These labeling requirements would help to discourage use of sunlamp products by those populations that are especially susceptible to the risk of skin cancer—persons under the age of 18 and persons with a prior personal history or family history of skin cancer. When combined with the labeling requirements of the sunlamp performance standard in § 1040.20, this labeling would help clearly communicate the risks of skin cancer to all users. A warning directing users of this device who are repeatedly exposed to sunlamp products to be regularly evaluated for skin cancer would help to clearly communicate the increased risk of skin cancer from cumulative UV radiation exposure and help to mitigate that increased risk. Clear communication of these risks and identification of susceptible populations would help potential users make an informed choice about use of sunlamp products and mitigate the increased risk of skin cancer from cumulative UV radiation exposure in all users by encouraging judicious use of these devices. This labeling would also help to mitigate other risks of use of sunlamp products, including discomfort, pain, and tenderness resulting from burns to the skin due to acute overexposure to UV radiation.
VII. Premarket Notification Back to Top
Class II devices are subject to the 510(k) premarket notification requirement unless exempted under section 510(m) of the FD&C Act. Under this proposed reclassification, the Agency does not propose to exempt these devices from premarket notification (510(k)) submission requirements as provided for under section 510(m) of the FD&C Act. The premarket notification requirement allows the Agency to review the technological characteristics, performance, intended use(s), and labeling of medical devices to ensure the devices are substantially equivalent to legally marketed predicate devices before they enter the market. Substantial equivalence requires that a new device must have (1) the same intended use as legally marketed predicates, and (2) either the same technological characteristics as a legally marketed predicate, or if there are significant differences, the differences must not raise new questions of safety and effectiveness and the performance data must demonstrate that the new device is at least as safe and effective as the legally marketed predicate device. (See section 513(i) of the FD&C Act.) This assures that new devices that differ significantly in terms of safety and effectiveness from devices already legally on the market will be subject to the more rigorous premarket approval requirement.
VIII. Implementation Strategy Back to Top
Sunlamp product models that have not been marketed prior to the effective date of a final order based on this proposal, or have been marketed but are required to submit a new 510(k) under § 807.81(a)(3) because the device is about to be significantly changed or modified:
FDA would expect manufacturers of these devices to obtain 510(k) clearance and comply with all special controls before marketing the new or changed device.
Individual sunlamp products that have been shipped to operators or users such as salons and individual consumers before the effective date of a final order: FDA would expect manufacturers to provide updated labeling that complies with the labeling special controls in proposed § 878.4635(b)(6) (21 CFR 878.4635(b)(6)) to operators or users within 1 year of the effective date of a final order.
In addition, FDA concludes that the labeling statements in proposed § 878.4635(b)(6)(i), (b)(6)(iii), and (b)(6)(iv) do not constitute a “collection of information” under the PRA. Rather, the labeling statements are “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public.” (5 CFR 1320.3(c)(2)).
FDA's proposed implementation strategy. In particular, what is the most practical method for manufacturers of devices currently on the market to conform to the labeling special control in proposed § 878.4635(b)(6) before 1 year after the effective date of the final order?
XIII. Codification of Orders Back to Top
Prior to the amendments by FDASIA, section 513(e) provided for FDA to issue regulations to reclassify devices. Although section 513(e) as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this proposed order, we are proposing to revoke the requirements in § 878.4635 related to the classification of UV lamps for tanning as class I devices and to codify the reclassification of sunlamp products into class II.
48. Harrison, S.L., R. MacLennan, and P.G. Buettner, “Sun Exposure and the Incidence of Melanocytic Nevi in Young Australian Children,”Cancer Epidemiology, Biomarkers & Prevention, vol. 17, pp. 2318-2324, 2008.
1.The authority citation for 21 CFR part 878 continues to read as follows: Authority:
2.Section 878.4635 is revised to read as follows: § 878.4635 Sunlamp product.
1. Ocular risks are addressed by labeling and performance requirements regarding eyewear at § 1040.20.
2. See FDA's guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” (available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm), for additional guidance on whether a device change or modification requires a 510(k) submission.