Source: https://www.federalregister.gov/articles/2014/06/02/2014-12546/general-and-plastic-surgery-devices-reclassification-of-ultraviolet-lamps-for-tanning-henceforth-to
Timestamp: 2015-05-27 09:53:22
Document Index: 726083001

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

Federal Register | General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products
Dates: This order is effective September 2, 2014. See further discussion in section V ``Implementation Strategy'' for compliance dates.
-31214 (10 pages)
Document Number: 2014-12546
Shorter URL: https://federalregister.gov/a/2014-12546 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, rather than through the administrative order procedures that apply to this 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 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 (f)(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).
On July 9, 2012, Congress enacted FDASIA. Section 608(a) of FDASIA amended the device reclassification procedures under section 513(e) of the FD&C Act, changing the process from rulemaking to an administrative order. Prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD Act; and (3) consideration of comments to a public docket. The proposed reclassification order must set forth the proposed reclassification and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including the public health benefits of the use of the device, and the nature and incidence (if known) of the risk of the device. (See section 513(e)(1)(A)(i) of the FD Act.) FDA issued a proposed reclassification order for the devices that are the subject of this final reclassification order on May 9, 2013 (78 FR 27117).
FDA also regulates electronic products, including sunlamp products and UV lamps intended for use in sunlamp 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. Sunlamp products and UV lamps intended for use in 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 and UV lamps intended for use in 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 and UV lamps intended for use in 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 product and UV lamp 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 (Pub. L. 110-85).
(Comment 1) Why is the Agency using such a broad interpretation of the term “sunlamp product” that includes sunlamp products and UV lamps? The Agency's treatment of these products as a single class of product is inconsistent with the performance standard at § 1040.20, which identifies them as distinct products. By treating them as a single class of product, FDA is ignoring differences in physical characteristics between these products.
(Response 1) Prior to this reclassification, UV lamps intended to tan the skin and sunlamp products incorporating UV lamps were regulated together under the same classification regulation, § 878.4635 (21 CFR 878.4635), as class I 510(k)-exempt devices (subject to the limitations in 21 CFR 878.9, Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act). Manufacturers appear to have understood that this classification included both sunlamp products and UV lamps, since they have been listing both products under the same product code in the Agency's Registration and Listing database.
In the proposed reclassification order, FDA proposed to rename the classification regulation from “ultraviolet lamps for tanning” to “sunlamp products,” but after considering comments submitted in response to the proposed order, FDA believes the proposed renaming would not be sufficiently clear in its inclusion of both sunlamp products and UV lamps intended for use in sunlamp products. Thus, in this final order, FDA has renamed the regulation and revised the definition of the product in § 878.4635(a) to more clearly indicate that the regulation includes both sunlamp products and UV lamps intended for use in sunlamp products. This language is consistent with the terminology used in the performance standard for these products in § 1040.20.
FDA acknowledges that there are differences between sunlamp products and UV lamps intended for use in sunlamp products, and so has made clear in this final order that certain labeling requirements (see § 878.4635(b)(6)(i)) apply only to sunlamp products whereas other labeling requirements (see § 878.4635(b)(6)(ii)) apply to both sunlamp products and and UV lamps intended for use in sunlamp products. Further, FDA is requiring that the labeling special control at § 878.4635(b)(6)(i)(A) be placed in a black box. For devices that have significant risks that would make the devices unsafe if used inappropriately, FDA may require that the risks be explained in warning statements placed in a black box that is displayed prominently in the labeling to ensure awareness by the end user. In conjunction with other regulatory controls, awareness of these important risks by the end user enables these devices to be used safely. In this case, a prominent black box warning that identifies individuals who should not use the device is necessary to allow sunlamp products to be used safely.
Although Reference 1 (Reference 15 in the proposed order) was published after the panel meeting, its conclusion—that users with a history of melanoma are at an increased risk for melanoma reoccurrence—is also discussed in research published in 2006 by Freedman, et al. (Ref. 2), which was known at the time of the panel meeting.
(Response 5) Advisory committees provide FDA with independent advice from outside experts. FDA's advisory committee program is governed by a number of Federal laws and regulations that set forth standards for convening advisory committees and reviewing potential conflicts of interest. FDA remains committed to ensuring that its advisory committee process is conducted according to applicable statutes and regulations and consistent with relevant FDA guidance. These laws, regulations, and guidance documents are available on our Web site, and provide ready access to the statutory and regulatory framework that FDA advisory committees operate within and describe the steps that FDA has taken to enhance decisionmaking, increase transparency, and strengthen public confidence in our advisory committee program.
FDA disagrees with the comment that the composition of the 2010 panel was flawed. A copy of the panel roster can be found at the FDA's Web site (Ref. 8). The 2010 panel members were screened for potential or actual conflicts of interest in accordance with legal requirements and consistent with FDA guidance, and were cleared by the Agency to participate at the meeting.
As indicated on the panel roster, there was a consumer representative, an industry representative, and a patient representative on the 16-person panel.
(Comment 7) Because FDA has not disclosed what the Agency will ultimately require under amendments to § 1040.20, industry cannot adequately comment on the proposed reclassification order.
(Response 7) Manufacturers must comply with the requirements set forth in § 1040.20. If, in the future, § 1040.20 is updated, as FDA has announced its intent to do, it will be done through its own notice and comment rulemaking process and stakeholders will be provided the opportunity to comment during that process.
(Comment 8) FDA should update the requirements in § 1040.20 prior to the implementation of this reclassification because 510(k)s for these products that are submitted prior to the performance standard amendments would not necessarily comply with the performance standard and could require manufacturers to have to submit additional 510(k)s for their products.
(Response 8) With respect to § 1040.20, manufacturers must comply with the performance standard in effect at the time of the 510(k) submission. If the performance standard is amended, manufacturers would not need to submit a new 510(k) unless there are significant changes to the device that trigger the need for a new 510(k) submission under 21 CFR 807.81(a)(3) (see FDA's guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device” (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm)).
(Response 10) Manufacturers of sunlamp products or UV lamps intended for use in sunlamp products that are offered for sale prior to September 2, 2014, must submit a 510(k) and comply with the labeling special controls established in this final order by August 26, 2015, which is 15 months from the date of publication of this final order (see section V “Implementation Strategy”) for any device they wish to continue offering for sale. Manufacturers can continue offering these products for sale while FDA reviews the 510(k) submissions. However, if a 510(k) is not submitted or the device is not in compliance with the labeling special controls by this date, or if FDA determines after review of the 510(k) that the device is not substantially equivalent to a legally marketed predicate device or the device is not in compliance with the labeling or other special controls, the device, including individual devices already in use, would be adulterated and misbranded under sections 501(f)(1)(B) and 502(o) of the FD&C Act, and the manufacturer would have to cease offering the device for sale.
(Response 11) Individual sunlamp products that have already been sold to end users prior to September 2, 2014, the model of which has been discontinued or is otherwise no longer marketed after this date, do not have to have 510(k)s or comply with the non-labeling special controls, but they must comply with the labeling special controls at § 878.4635(b)(6)(i)(A) by August 26, 2015. If the manufacturer is no longer in business, sunlamp product owners would have to apply the required labeling to sunlamp products to keep these devices in compliance with the labeling requirements.
(Response 12) In this final order, FDA has revised the classification identification to expressly include “sunlamp products” and “UV lamps intended for use in sunlamp products” and has included revised definitions of these devices, as discussed in response to Comment 1. A 510(k) submission is required for sunlamp products and for UV lamps intended for use in sunlamp products. If a UV lamp intended for use in a sunlamp product is sold with a sunlamp product or they are sold separately from one another, then both devices can be included in the same 510(k) submission. For more information on this issue, please see FDA Guidance, “Bundling Multiple Devices or Multiple Indications in a Single Submission,” available at http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089731.htm.
(Response 14) Instead of submitting separate 510(k)s for different lamp types, a manufacturer can submit a “bundled” 510(k) for related lamps. For more information on this issue, please see FDA Guidance, “Bundling Multiple Devices or Multiple Indications in a Single Submission,” available at http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089731.htm.
(Response 17) If a certain non-labeling special control does not, as a practical matter, apply to a device due to the device's nature or design, manufacturers may meet such special control by explaining such practical inapplicability in their 510(k) submission to FDA. For example, biocompatibility testing would not apply to a UV lamp that does not contact the human body and the software verification requirement would not apply to a UV lamp that does not employ software. As long as FDA finds such justification acceptable, the manufacturer would not have to conduct or submit any testing that would otherwise be required by that particular special control. FDA has chosen this flexible approach, as opposed to assigning certain special controls to certain types of sunlamp products and UV lamps intended for use in sunlamp products, to account for ever-changing technology in this area.
(Response 18) Based on comments we received, we have clarified the applicability of the labeling requirements in the final order. The labeling in § 878.4635(b)(6)(i) pertains only to sunlamp products while the labeling in § 878.4635(b)(6)(ii) pertains to sunlamp products and UV lamps intended for use in sunlamp products. This means that sunlamp products must comply with the requirements in § 878.4635(b)(6)(i) and (b)(6)(ii), while UV lamps intended for use in sunlamp products must comply with § 878.4635(b)(6)(ii) and not with § 878.4635(b)(6)(i).
(Comment 19) A font height of 10 millimeters (mm) is too small for the labeling prescribed in proposed § 878.4635(b)(6)(i).
SEER Melanoma
(Comment 24) The IARC report shows only a1/10of 1 percent increase in risk of melanoma. The IARC report clearly states that epidemiologic studies do not support a consistent relationship between tanning and cancer.
(Response 24) FDA is unaware of the source of the1/10of 1 percent value referenced by the commenter. Rather, the IARC report identified a causal relationship between indoor tanning and melanoma risk based on evidence pertaining to the strength, consistency, dose-response and temporal sequence of the association of the use of sunlamp products with melanoma risk, and of the coherence and biologic plausibility of the association (Ref. 13). Additionally, the study found that first exposure to sunlamp products before age 35 increased the risk of melanoma by 75 percent compared to individuals that never used sunlamp products.
(Comment 31) Regulated tanning facilities are a safer alternative than home tanning where there are no informed workers. Tanning facility owners are trained and educated to protect clients who want to tan.
(Response 32) Devices prescribed for individuals with dermatological disorders have been and will continue to be regulated differently from devices regulated under § 878.4635. UV lamps for dermatological disorders have long been class II medical devices regulated under 21 CFR 878.4630 and are unaffected by this reclassification.
IV. Premarket Notification Back to Top
FDA cleared several 510(k)s for sunlamp products prior to exempting the devices from premarket notification submission.
At least one 510(k) for a sunlamp product has been cleared since then under product code LEJ. These cleared sunlamp products, as well as any 510(k)-exempt sunlamp product or UV lamp intended for use in a sunlamp product legally offered for sale on or before September 2, 2014, can serve as predicates for substantial equivalence purposes.
Models of sunlamp products and UV lamps intended for use in sunlamp products that have not been offered for sale prior to September 2, 2014, or have been offered for sale 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:
Manufacturers must obtain 510(k) clearance before marketing the new or changed device.
Individual sunlamp products that have been shipped to operators or users such as tanning facilities and individual consumers prior to September 2, 2014, the model of which has been discontinued or is otherwise no longer offered for sale: These devices must comply with the labeling special controls at § 878.4635(b)(6)(i)(A) by August 26, 2015. If the manufacturer is no longer in business, sunlamp product owners would have to apply the required labeling to keep these devices in compliance with the labeling requirements.
In addition, FDA concludes that the labeling statements in § 878.4635(b)(6)(i)(A) and (b)(6)(ii)(A) through (b)(6)(ii)(D) 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)).
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 final order, we are revoking the requirements in § 878.4635 related to the classification of UV lamps for tanning as class I devices and codifying the reclassification of sunlamp products and UV lamps intended for use in sunlamp products into class II.
1. Salama, A.K., N. de Rosa, R.P. Scheri, et al., “Hazard-Rate Analysis and Patterns of Recurrence in Early Stage Melanoma: Moving Towards a Rationally Designed Surveillance Strategy,”PLoS One, vol. 8, pp. e576-e665, 2013.
2. Freedman, D.B., B.A. Miller, and M.A. Tucker, “New Malignancies Following Melanoma of Skin, Eye Melanoma, and Nonmelanoma Eye Cancer,”New Malignancies Among Cancer Survivors: SEER Cancer Registries, 1973-2000, pp. 339-362, 2006.
3. Reed, K.B., J.D. Brewer, C.M. Lohse, et al., “Increasing Incidence of Melanoma Among Young Adults: An Epidemiological Study in Olmsted County, Minnesota,”Mayo Clinic Proceedings, vol. 87, pp. 328-334, 2012.
4. Cust, A.E., B.K. Armstrong, C. Goumas, et al., “Sunbed Use During Adolescence and Early Adulthood Is Associated With Increased Risk of Early-Onset Melanoma,”International Journal of Cancer, vol. 128, pp. 2425-2435, 2011.
5. Stapleton, J.L., J. Hillhouse, R. Turrisi, et al., “Erythema and Ultraviolet Tanning: Findings From a Diary Study,”Translational Behavioral Medicine, vol. 3, pp. 10-16, 2013.
6. Cokkinides, V., M. Weinstock, D. Lazovich, et al., “Indoor Tanning Use Among Adolescents in the United States, 1998-2004,”Cancer, vol. 115, pp. 190-198, 2009.
8. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM205686.pdf.
9. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM383896.pdf.
10. Sivamani, R.K., L.A. Crane, R.P. Dellavalle, et al.,” The Benefits and Risks of Ultraviolet Tanning and Its Alternatives: The Role of Prudent Sun Exposure,”Dermatologic Clinics, vol. 27, pp. 149-154, 2009.
11. Autier, P. and P. Boyle, “Artificial Ultraviolet Sources and Skin Cancers: Rationale for Restricting Access to Sunbed Use Before 18 Years of Age,”Nature Clinical Practice Oncology, vol. 5(4), pp. 178-179, 2008.
12. National Institutes of Health, Office of Dietary Supplements, “Dietary Supplement Fact Sheet: Vitamin D” (http://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional).
13. “IARC Working Group on Artificial Ultraviolet Light (UV) and Skin Cancer: The Association of Use of Sunbeds With Cutaneous Malignant Melanoma and Other Skin Cancers: A Systematic Review,''International Journal of Cancer, vol. 120, pp. 1116-1122, 2006.
14. SEER Stat Fact Sheets: Melanoma of the Skin, http://seer.cancer.gov/statfacts/html/melan.html#incidence-mortality.
15. SEER Cancer Statistics Review 1975-2010, http://seer.cancer.gov/csr/1975_2010/browse_csr.php?sectionSEL=16&amp;pageSEL=sect_16_table.05.html.
16. Gallagher, R.P., J.J. Spinelli, and T.K. Lee, “Tanning Beds, Sunlamps, and Risk of Cutaneous Malignant Melanoma,”Cancer Epidemiology, Biomarkers & Prevention, vol. 14(3), pp. 562-566, 2005.
17. Boniol, M., P. Autier, P. Boyle, et al., “Cutaneous Melanoma Attributable to Sunbed Use: Systematic Review and Meta-Analysis,”British Medical Journal, vol. 345, p. e4757 July 24, 2012.
18. Doré, J. and M.C. Chignol, “Tanning Salons and Skin Cancer,”Photochemical & Photobiological Sciences, vol. 11(1), pp. 30-37, 2012.
19. http://www.google.com/url?sa=t&amp;rct=j&amp;q=&amp;esrc=s&amp;source=web&amp;cd=1&amp;ved=0CCkQFjAA&amp;url=http%3A%2F%2Ftancanada.org%2Fwp-content%2Fuploads%2F2013%2F05%2Fsuntan_poster_4-final-Montreal.pdf&amp;ei=u8B8U7iiFdbesATr7oGoCA&amp;usg=AFQjCNFNmLHAAiGcthuPeFfKj94zhexEaw&amp;sig2=IZO-wr4jPtD8ql5fvhV7Vg&amp;bvm=bv.67229260,d.cWc&amp;cad=rja.
20. Grant, W.B., “Critique of the International Agency for Research on Cancer's Meta-Analyses of the Association of Sunbed Use With Risk of Cutaneous Malignant Melanoma,”Dermatoendocrinology, vol. 1(6), pp. 294-299, 2009.
21. Zhang, M., A.A. Qureshi, A.C. Geller, et al., “Use of Tanning Beds and Incidence of Skin Cancer,”Journal of Clinical Oncology, vol. 30, pp. 1588-1593, 2012.
22. Mayer, J.A., S.I. Woodruff, D.J. Slymen, et al., “Adolescents' Use of Indoor Tanning: A Large-Scale Evaluation of Psychosocial, Environmental, and Policy-Level Correlates,”American Journal of Public Health, vol. 101(5), pp. 930-938, 2011.
2.Section 878.4635 is revised to read as follows: § 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(c) Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at § 1040.20 of this chapter.
1. See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm product code LEJ.
2. See http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf.
4. 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.