[Federal Register Volume 79, Number 105 (Monday, June 2, 2014)]
[Rules and Regulations]
[Pages 31205-31214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12546]



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Rules and Regulations
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Federal Register / Vol. 79, No. 105 / Monday, June 2, 2014 / Rules 
and Regulations

[[Page 31205]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2013-N-0461]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final Order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reclassifying ultraviolet (UV) lamps intended to tan the skin from 
class I (general controls) exempt from premarket notification to class 
II (special controls) and subject to premarket notification, and 
renaming them sunlamp products and UV lamps intended for use in sunlamp 
products. FDA is designating special controls that are necessary to 
provide a reasonable assurance of safety and effectiveness of the 
device. FDA is reclassifying this device on its own initiative based on 
new information.

DATES: This order is effective September 2, 2014. See further 
discussion in section V ``Implementation Strategy'' for compliance 
dates.

FOR FURTHER INFORMATION CONTACT: Neil R.P. Ogden, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm.1438, Silver Spring, MD 20993-0002, 301-
796-6397.

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) establishes 
a comprehensive system for the regulation of medical devices intended 
for human use. Section 513 of the FD&C 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&C Act is a 
restriction on the sale, distribution, or use of a device under section 
520(e) of the FD&C 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&C Act, as amended by 
the Food and Drug Administration Safety and Innovation Act (FDASIA) 
(Pub. L. 112-144).
    Under section 513 of the FD&C Act, devices that were in commercial 
distribution before the enactment of the 1976 amendments, May 28, 1976 
(generally referred to as preamendments devices), are classified after 
FDA has: (1) Received a recommendation from a device classification 
panel (an FDA advisory committee); (2) published the panel's 
recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. Applying these procedures, FDA has classified 
most preamendments device types.
    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 (f)(3) of the FD&C Act or FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the FD&C 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&C 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&C 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&C 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).
    Section 513(e) provides that FDA may, by administrative order, 
reclassify a device based upon ``new information.'' FDA can initiate a 
reclassification under section 513(e) of the FD&C Act or an interested 
person may petition FDA. The term ``new information,'' as used in 
section 513(e) of the FD&C Act, includes information developed as a 
result of a reevaluation of the data before the Agency when the device 
was originally classified, as well as information not presented, not 
available, or not developed at that time. (See, e.g., Holland-Rantos 
Co. v. United States Department of Health, Education, and Welfare, 587 
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).) 
Whether data before the Agency are old or new data, the ``new 
information'' to support reclassification under section 513(e) must be 
``valid scientific evidence,'' as defined in 21 CFR 860.7(c)(2). (See, 
e.g., Gen. Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact 
Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 
474 U.S. 1062 (1986).)
    FDA also regulates electronic products, including sunlamp products

[[Page 31206]]

and UV lamps intended for use in sunlamp products, under chapter 5, 
subchapter C of the FD&C 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 Sec.  1040.20 (21 CFR 1040.20). The sunlamp 
products and UV lamps intended for use in sunlamp products performance 
standard in Sec.  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 Sec.  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 Sec.  
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).

II. Public Comments in Response to the Proposed Order

    FDA received over 2,500 comments in response to the proposed order. 
Many of these comments supported the proposal. The comments that 
expressed concerns raised many of the same issues as one another. The 
comments can be categorized in the following six areas: (1) Terminology 
and definitions, (2) procedural aspects of the classification, (3) 
510(k) notification, (4) special controls, (5) underlying science, and 
(6) miscellaneous comments. To make it easier to identify comments and 
our response to the comments, the word ``Comment'' appears before the 
description of the comment, and the word ``Response'' appears before 
our response. We have also numbered each comment to make it easier to 
identify a particular comment. The number assigned to each comment is 
purely for organizational purposes and does not signify the comment's 
value or importance or the order in which it was submitted.

A. Terminology and Definitions

    (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 Sec.  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, Sec.  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.\1\
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    \1\ See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm product code LEJ.
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    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 Sec.  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 
Sec.  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 
Sec.  878.4635(b)(6)(i)) apply only to sunlamp products whereas other 
labeling requirements (see Sec.  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 Sec.  
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.

B. Procedural Aspects of Classification

    (Comment 2) The proposed order cites several studies that were 
published subsequent to the March 2010 General and Plastic Surgery 
Advisory Panel (the ``panel''), underscoring the evolving science in 
this space. By not convening a new panel, is the Agency denying 
stakeholders a fair opportunity to address the methodology or other 
concerns related to studies on which the Agency is relying to take this 
action? Further, by failing to convene a panel, is the Agency failing 
to rely on up-to-date medical research?
    (Response 2) The 2010 panel considered all relevant scientific 
issues associated with sunlamp products and UV lamps intended for use 
in sunlamp products and recommended upclassifying these devices. FDA is 
not aware of any significant changes in benefits or risks relating to 
sunlamp products and UV lamps intended for use in sunlamp products that 
have been identified in the scientific literature since the 2010 panel 
meeting. The articles published since that meeting offer further 
support for the panel's recommendation.
    Of the 53 references cited in the proposed order, only 4 are 
scientific articles published after the 2010 panel. Although these four 
articles were published after the panel met to discuss reclassification 
of sunlamp products and UV lamps intended for use in sunlamp products, 
the substance therein is not ``new'' as it relates to issues considered 
at the 2010 panel. Specifically:
     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

[[Page 31207]]

Freedman, et al. (Ref. 2), which was known at the time of the panel 
meeting.
     References 3 and 4 (References 18 and 19 in the proposed 
order) discuss the effects of tanning in childhood and early adult 
life, which were discussed extensively by the panel. Some panel members 
favored an age restriction for indoor tanning (i.e., individuals under 
a certain age would not be permitted to use sunlamp products and UV 
lamps intended for use in sunlamp products) and thought that the cutoff 
age should be 18.
     As discussed in the proposed order, Reference 5 (Reference 
28 in the proposed order) showed that, despite protective measures 
instituted in commercial tanning facilities, 66 percent of female 
college-age users reported skin erythema from indoor tanning, and these 
users reported one episode of sunburn out of every five tanning 
sessions. These findings are consistent with an earlier report (Ref. 6) 
(Reference 29 in the proposed order) published in 2009 that showed that 
58 percent of adolescent indoor tanners had experienced sunburns from 
exposure to sunlamp products and UV lamps intended for use in sunlamp 
products.

Stakeholders had an opportunity to raise concerns relating to the 
underlying methodology of any studies FDA relied on in the proposed 
order in their comments on that proposed order. We have addressed such 
comments in the subsection ``E. Underlying Science'' in this document.
    (Comment 3) Using a panel meeting that took place prior to the 
issuance of the proposed reclassification order violates the sequence 
of events for issuing an administrative order to change the 
classification of a device as prescribed by section 513(e) of the FD&C 
Act, as amended by FDASIA.
    (Response 3) The process followed by FDA in reclassifying these 
devices is in accordance with the applicable statutory provisions, 
which were recently amended by FDASIA. Section 608 of FDASIA amended 
section 513(e) of the FD&C Act by changing the reclassification process 
from rulemaking to an administrative order process. The amendments to 
section 513(e) of the FD&C Act made by FDASIA, require, in relevant 
part, that issuance of an administrative order reclassifying a device 
be preceded by a proposed order and a meeting of a device 
classification panel.
    As amended, this section of the FD&C Act does not prescribe when 
these two events (the panel meeting and proposed order) must occur in 
relation to each other. Therefore, this provision provides the Agency 
with the flexibility to hold a panel meeting either before or after the 
issuance of a proposed reclassification order. This approach is 
consistent with the prior panel provision in section 513(e), which 
provided for FDA, at its discretion, to secure a panel recommendation 
prior to the promulgation of a reclassification rule and reflects 
longstanding practice. Indeed, prior to FDASIA, when a panel meeting 
was discretionary, FDA often held a panel meeting prior to proposing 
reclassification of a device, for example, when the Agency determined 
that a recommendation from the panel would help inform whether 
proposing reclassification for the device was appropriate. FDA believes 
its interpretation of section 513(e), as amended by FDASIA, is 
reasonable and allows the Agency to carry out the reclassification of 
devices in the most efficient and effective manner for the Agency and 
all stakeholders.
    FDA believes the panel's deliberations and recommendations from the 
meeting held in March 2010 concerning potential changes to the current 
classification or regulatory controls for sunlamp products and UV lamps 
intended for use in sunlamp products remain relevant and fully satisfy 
the requirements in section 513(e) of the FD&C Act. As explained in the 
proposed reclassification order (Ref. 7), ``No significant changes in 
risks relating to [sunlamp products and UV lamps intended for use in 
sunlamp products] have been identified in the scientific literature 
since the 2010 panel meeting; the same risks identified prior to the 
2010 panel meeting continue to be presented in literature.'' Therefore, 
convening another panel meeting on the reclassification of sunlamp 
products and UV lamps intended for use in sunlamp products would be 
unnecessarily duplicative and an inefficient use of the time and 
resources of all relevant parties.
    (Comment 4) Comments were submitted to the record in connection 
with the 2010 panel meeting, including a scientific critique of the 
scientific papers on which FDA had relied. FDA's proposed order fails 
to address or discuss the scientific submissions made by the 
stakeholders. Did FDA take these submissions into account, and, if so, 
how were they addressed in the proposed order?
    (Response 4) Stakeholders submitted 139 comments to the docket for 
the 2010 panel meeting (Docket No. FDA-2009-N-0606). Although FDA's 
proposed order does not directly discuss each specific comment, the 
Agency did review and consider all received comments in the development 
of its proposed reclassification of sunlamp products and ultraviolet 
lamps intended for use in sunlamp products. The proposed order includes 
the following summary of the comments ``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 (Ref. 7).''
    FDA considered not only the comments received in the docket to the 
2010 panel meeting, but also relevant scientific literature, both in 
favor of and against the use of sunlamp products. As required by 
section 513(e) of the FD&C Act, as amended by FDASIA, the proposed 
order provided a substantive summary of the valid scientific evidence 
concerning the proposed reclassification of the device, including the 
available information on the benefits of use of sunlamp products, as 
well as the risks to health from use of these products. The proposed 
order also called for comments from any interested stakeholders. The 
comment period on the proposed order closed on August 7, 2013. All 
comments received were considered by the Agency prior to development of 
this final reclassification order.
    (Comment 5) The 2010 panel was not representative of industry and 
certain members of the panel had a conflict of interest because they 
were partnered with the American Academy of Dermatology (AAD).
    (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

[[Page 31208]]

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.\2\ As indicated on the panel roster, there 
was a consumer representative, an industry representative, and a 
patient representative on the 16-person panel.
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    \2\ See http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf.
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    (Comment 6) Prior to the 2012 enactment of FDASIA, classifications 
under section 513(e) of the FD&C Act were governed by the Federal 
rulemaking process requiring economic analysis of any proposed 
regulations. At any time after the Agency commenced its 
reclassification efforts with respect to sunlamp products and UV lamps 
intended for use in sunlamp products in 2009, did the Agency undertake 
any formal or informal economic analysis of possible changes to the 
regulation of this product?
    (Response 6) The Federal rulemaking process requires economic 
analysis of proposed rules under Executive Order 12866. Section 608 of 
FDASIA amended section 513(e) of the FD&C Act by changing the 
reclassification process from rulemaking to an administrative order 
process. This order process is not subject to Executive Order 12866. 
Therefore, although the Agency considered the impact on stakeholders 
and the least burdensome method to secure a reasonable assurance of 
safety and effectiveness for sunlamp products and UV lamps intended for 
use in sunlamp products, the Agency has not conducted an economic 
analysis for reclassification of these devices.
    FDA did consider the impact that this reclassification may have on 
small businesses and has decided to employ a staged implementation plan 
to minimize the burden on affected entities. Small businesses play an 
important role in the medical device industry and are responsible for 
more than half of all medical devices under development, including 
sunlamp products and UV lamps intended for use in sunlamp products. 
Given this role, FDA recognizes how critical it is that small firms 
understand the regulatory landscape in order to meet regulatory 
requirements for marketing. The Division of Industry and Consumer 
Education (DICE) in the Center for Devices and Radiological Health 
(CDRH) is dedicated to helping small businesses successfully navigate 
the Agency's device approval and clearance processes. In addition, 
small businesses may qualify for substantially discounted user fees--a 
510(k) submission fee for a small business in FY 2014 is $2,585, which 
is half the standard 510(k) submission fee.
    (Comment 7) Because FDA has not disclosed what the Agency will 
ultimately require under amendments to Sec.  1040.20, industry cannot 
adequately comment on the proposed reclassification order.
    (Response 7) Manufacturers must comply with the requirements set 
forth in Sec.  1040.20. If, in the future, Sec.  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 Sec.  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 Sec.  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)).

C. 510(k) Notification

    (Comment 9) Has FDA conducted any analysis of the increased 
resources it will need to enforce these new regulations, including the 
demands placed on the Agency to review 510(k) premarket notifications?
    (Response 9) A review of FDA's Establishment Registration and 
Device Listing database, which identifies, among other things, 
manufacturers that are registered to market medical devices and the 
devices that they currently market, shows that there are approximately 
25 firms registered as sunlamp product manufacturers or manufacturers 
of UV lamps intended for use in sunlamps products. To continue offering 
these devices for sale, a 510(k) must be submitted by August 26, 2015, 
(see further discussion in section V ``Implementation Strategy''). 
Thus, FDA expects to receive approximately 25 510(k) submissions within 
this timeframe (and potentially a few other 510(k) submissions for new 
sunlamp products and UV lamps intended for use in sunlamp products). 
FDA typically receives and reviews approximately 4,000 510(k) 
submissions each year, so the Agency does not expect the 
reclassification of sunlamp products and UV lamps intended for use in 
sunlamp products to significantly affect review times or resources.
    As a part of the Medical Device User Fee Amendments of 2012, or 
MDUFA III, FDA committed to meeting certain review times for 510(k) 
submissions. FDA's current review goal for 510(k) submissions is to 
make a substantial equivalence determination within 90 days of active 
FDA review. The latest published review data from January 29, 2014, 
shows that FDA has met its review goal for 100 percent of the 510(k) 
submissions received in fiscal year 2014, to date. FDA expects to meet 
these review goals for any 510(k) submission for sunlamp products or UV 
lamps intended for use in sunlamp products (Ref. 9).
    (Comment 10) Can the Agency clarify by when it expects 
manufacturers to submit a 510(k) notification for products already 
being offered for sale, and whether those products can continue to be 
offered for sale after submission of the 510(k) notification but prior 
to Agency clearance?
    (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

[[Page 31209]]

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.
    (Comment 11) The proposed order is silent on the status of products 
that are already on the market for which the manufacturer is no longer 
in business or for which it is not economically viable for the 
manufacturer to incur the costs associated with submitting a 510(k).
    (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 
Sec.  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.
    (Comment 12) Is one 510(k) required for a ``sunlamp product,'' 
which by definition includes a fixture and UV lamp, or are separate 
510(k)s required for the sunlamp product and UV lamp? Similarly, if UV 
lamps are sold with a sunlamp product and on their own, do multiple 
510(k)s need to be submitted?
    (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.
    (Comment 13) If FDA is requiring that UV lamp manufacturers submit 
510(k)s for their lamps, are lamp manufacturers required to submit 
separate 510(k)s for use of their lamps in each tanning bed or booth? 
Or, can UV lamp manufacturers that are required to submit 510(k)s for 
their lamps do so without referencing use of the lamp with a particular 
tanning bed or booth? Is a replacement UV lamp manufacturer required to 
submit a separate 510(k) for use of each replacement lamp type in each 
possible tanning bed or tanning booth in which the replacement lamp 
could conceivably be used?
    (Response 13) Manufacturers of UV lamps that submit a 510(k) do not 
need to submit a separate 510(k) for use of each replacement lamp type 
in each possible tanning bed or tanning booth in which the replacement 
lamp could conceivably be used, but they should specify in their 510(k) 
submission the design characteristics of the sunlamp product with which 
the lamp is compatible.
    (Comment 14) If FDA is requiring that all UV lamp manufacturers, 
including replacement lamp manufacturers, submit 510(k)s, is a 
manufacturer of replacement UV lamps required to submit a separate 
510(k) for each of its lamp types? Will the Agency accept 510(k)s for 
lamp model families?
    (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.
    (Comment 15) Sunlamp product and UV lamp manufacturers are aware of 
cleared 510(k)s for ``UV lamps for tanning,'' but at least some of 
these 510(k)s are over 20 years old. Over the past 20 years, sunlamp 
products and UV lamps have improved substantially with regard to 
performance and safety. Sunlamp product and UV lamp manufacturers are 
uncertain how to show substantial equivalence to one of the 20-year-old 
sunlamp products or UV lamps given these significant improvements.
    (Response 15) FDA will find a contemporary sunlamp product or UV 
lamp intended for use in a sunlamp product to be substantially 
equivalent to a predicate device if the contemporary device: (1) Has 
the same intended use as the predicate device and (2) has the same 
technological characteristics as the predicate device or has different 
technological characteristics but is at least as safe and effective as 
the predicate device and does not raise new questions of safety or 
effectiveness. If the device has different technological 
characteristics from the predicate device, the 510(k) submission must 
include a summary of how the technological characteristics of the 
device compare to a legally marketed predicate device (21 CFR 
807.92(a)(6)). In addition to showing substantial equivalence, 
manufacturers of new sunlamp products will need to show compliance with 
the special controls required under this order.
    (Comment 16) FDA should ``grandfather'' in all currently legally 
marketed sunlamp products, such that they would not be subject to the 
requirements set forth in this order. Moreover, these products should 
be allowed to be used as predicate devices as long as the manufacturers 
provide adequate documentation that the products meet all requirements 
necessary for a 510(k) submission.
    (Response 16) Manufacturers of sunlamp products or UV lamps 
intended for use in sunlamp products that are offered for sale prior to 
September 2, 2014, are required to submit 510(k)s and must comply with 
the labeling special controls by August 26, 2015, for any device they 
wish to continue offering for sale. Any sunlamp product or UV lamp 
intended for use in a sunlamp product legally marketed on or before 
September 2, 2014, including both 510(k)-cleared and 510(k)-exempt 
devices, can be used as a predicate device in a 510(k). A 510(k) for 
such a device must demonstrate that the device was legally offered for 
sale on or before September 2, 2014, and it must comply with the 
special controls.

D. Special Controls

    (Comment 17) Many of the proposed special controls are either 
unrelated to UV lamps intended to be used with sunlamp products or are 
impossible for UV lamp manufacturers to achieve without involvement of 
a tanning bed or tanning booth. For example, UV lamps do not come into 
contact with indoor tanners due to safety issues associated with heat 
generation and possible lamp breakage. Given this, how would UV lamp 
manufacturers conduct biocompatibility testing or comply with some of 
the other special controls that may apply only to sunlamp products?
    (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

[[Page 31210]]

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.
    (Comment 18) FDA's proposed reclassification order would require 
that certain warning labeling appear on ``sunlamp product fixtures.'' 
Given that FDA specifies that the warning must appear on ``sunlamp 
product fixtures,'' does this special control apply to UV lamps?
    (Response 18) Based on comments we received, we have clarified the 
applicability of the labeling requirements in the final order. The 
labeling in Sec.  878.4635(b)(6)(i) pertains only to sunlamp products 
while the labeling in Sec.  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 Sec.  
878.4635(b)(6)(i) and (b)(6)(ii), while UV lamps intended for use in 
sunlamp products must comply with Sec.  878.4635(b)(6)(ii) and not with 
Sec.  878.4635(b)(6)(i).
    (Comment 19) A font height of 10 millimeters (mm) is too small for 
the labeling prescribed in proposed Sec.  878.4635(b)(6)(i).
    (Response 19) FDA believes 10 mm is sufficient height to attract 
attention and warn prospective users that individuals under age 18 
should not use the device. Ten mm is a minimum; labels are permitted to 
display font greater than 10 mm.

E. Underlying Science

    (Comment 20) The recent information cited by FDA in the proposed 
reclassification order is comprised solely of recent reviews of 
information that has been available for several years, and this 
information does not compel a change to the current classification or 
performance standards.
    (Response 20) The articles referenced in the proposed order qualify 
as ``new information'' under section 513(e) of the FD&C Act. The term 
``new information,'' as used in section 513(e) of the FD&C Act, 
includes information developed as a result of a reevaluation of the 
data before the Agency when the device was originally classified, as 
well as information not presented, not available, or not developed at 
that time. (See, e.g., Holland-Rantos Co. v. United States Department 
of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 
366 F.2d 177 (7th Cir. 1966).). The sources cited in the proposed 
reclassification order are all encompassed by this definition and 
reveal, among other things, that UV radiation is a significant 
contributing factor in developing skin cancer, that the number of 
females exposed to indoor UV radiation who are diagnosed with skin 
cancer is increasing, and that individuals under 18 who are exposed to 
UV radiation are at an increased risk of developing skin cancer. As 
stated in the proposed order, the cumulative effects of UV radiation 
exposure have been linked to higher incidence of skin cancer (Ref. 10). 
Moreover, individuals under 18 are particularly vulnerable to the 
damaging effect of UV radiation. According to a 2008 article 
recommending an age restriction to prevent sunlamp product use in 
children and teenagers, a number of biological factors are identified 
as potentially causing the increase in the risk of developing melanoma 
from exposure to sunlamps during those years (Ref. 11). These findings 
have compelled a change in how FDA regulates these devices.
    (Comment 21) Sunlamp products can stimulate the body to produce 
vitamin D. In addition to bone problems and increased cancer risk, 
vitamin D deficiency has been linked to a heightened risk of Type 1 
diabetes, multiple sclerosis and other autoimmune diseases, infectious 
diseases such as influenza and tuberculosis, and high blood pressure. 
For these reasons, additional regulation of sunlamp products is not 
appropriate.
    (Response 21) FDA agrees that vitamin D is critical for the body's 
health. In the proposed order, FDA acknowledged that UV radiation 
stimulates the body's production of vitamin D, however, there are safer 
alternatives to obtain vitamin D other than the use of sunlamp products 
and UV lamps intended to be used in sunlamp products, for example, 
through an individual's diet (Ref. 12). As stated previously, FDA 
believes that additional regulation is necessary to provide a 
reasonable assurance of safety and effectiveness of these devices.
    (Comment 22) FDA should not rely on the International Agency for 
Research on Cancer's (IARC) study (Ref. 13) to support this 
reclassification because that study included outdoor sun exposure and 
dermatology exposure, which confounded the data and exaggerated the 
effects of UV radiation.
    (Response 22) As with most indoor tanning risk studies, it can be 
difficult to discern for each subject the relative amounts of indoor 
and outdoor UV exposure. However, previous use of a sunlamp product and 
frequency of use can be assessed to determine relative risk of indoor 
tanning exposure. All of the studies analyzed in the IARC study focused 
on indoor tanning and melanoma as well as other skin cancers such as 
basal cell carcinoma and squamous cell carcinoma. FDA believes the IARC 
report's conclusions are applicable to indoor tanning.
    (Comment 23) Even though women's use of indoor tanning devices has 
increased in recent years, SEER cancer incidence data shows that the 
incidence of melanoma has decreased from 5.0 in 1975-1982 to 2.3 in 
1981-2010 in females (Ref. 14). This finding undermines the argument 
that indoor tanning causes melanoma.
    (Response 23) The SEER incidence data referenced in the comment is 
incorrect. In the SEER data, an increase in the incidence of melanoma 
in females has been noted since 1975 and has not abated. The age 
adjusted rates of melanoma for females per 100,000 are as follows (Ref. 
15):

                                 Table 1
------------------------------------------------------------------------
                                                          SEER  Melanoma
                                                             incidence
                          Year                              per 100,000
                                                              females
------------------------------------------------------------------------
1975....................................................            7.44
1980....................................................            9.63
1985....................................................           11.16
1990....................................................           11.84
1995....................................................           13.81
2000....................................................           15.50
2005....................................................           18.41
2010....................................................           19.30
------------------------------------------------------------------------

    The increase in melanoma incidence among white females is even 
greater (Ref. 15):

                                 Table 2
------------------------------------------------------------------------
                                                          SEER  melanoma
                                                             incidence
                          Year                              per 100,000
                                                          white  females
------------------------------------------------------------------------
1975....................................................            8.21
1980....................................................           11.12
1985....................................................           12.70
1990....................................................           13.93
1995....................................................           16.47
2000....................................................           19.08
2005....................................................           23.14
2010....................................................           24.23
------------------------------------------------------------------------

    (Comment 24) The IARC report shows only a \1/10\ of 1 percent 
increase in risk of melanoma. The IARC report clearly

[[Page 31211]]

states that epidemiologic studies do not support a consistent 
relationship between tanning and cancer.
    (Response 24) FDA is unaware of the source of the \1/10\ of 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 25) The cause of melanoma is unknown, although most 
scientists believe the primary cause is genetic in nature. The personal 
risk factors for melanoma include red hair, extremely pale skin that 
will not tan, presence of moles and freckles on the body, and a family 
history of melanoma. Upclassifying these devices, and limiting exposure 
to UV radiation, is not necessary for those without a genetic 
predisposition to melanoma.
    (Response 25) Although personal risk factors can also contribute to 
the risk for melanoma, there have been multiple studies which have 
found that sunlamp product use increases the risk of melanoma. Meta 
analyses by Gallagher et al. (Ref. 16), IARC (Ref. 13), and Boniol et 
al. (Ref. 17) have all found a link between sunlamp product use and 
melanoma.
    (Comment 26) The literature is replete with conflicting 
information, including science suggesting that moderate, non-burning UV 
exposure reduces the risk of melanoma and that sunburn is the relevant 
exposure circumstance to be avoided, whether the UV comes from the sun 
or from a tanning bed, and whether the person is older or younger than 
18. Sunburn prevention as the correct approach is supported by research 
showing that biologically, sunburn affects the skin differently when 
compared to non-burning UV exposure. Sunburning should be avoided, but 
moderate exposure by individuals--regardless of the user's age--is not 
risky.
    (Response 26) As stated in FDA's proposed order to reclassify these 
devices, there is no evidence that moderate non-burning UV exposure or 
attaining a ``base tan'' provides any protection against premature 
aging of the skin or reduces the risk of skin cancer (Ref. 7). The 
Agency concurs with the comment that there are other risk factors for 
melanoma besides sunbed use.
    (Comment 27) Dr. David G. Hoel, 1 of the 20 scientists that were 
called upon by the IARC in 2009 to reassess the carcinogenicity of all 
forms of radiation, has written a report stating that the 2006 IARC 
conclusion that there is a 75 percent increase in melanoma risk when 
tanning starts before age 35 is invalid. Dr. Hoel is preparing an 
article for publication on the subjects of melanoma, UV radiation, and 
the IARC report. The purpose of this article is to correct the many 
misconceptions about the science regarding UV radiation and melanoma 
that have been promoted by the AAD and other anti-tanning advocates. 
Dr. Hoel argues that the significant differences between regulatory 
standards in the United States and Europe with regard to use of sunlamp 
products make the predominantly European data in the IARC report an 
inappropriate basis for the FDA's decision to change the controls 
applicable to sunlamp products in the United States.
    (Response 27) The paper alluded to has not been published or 
undergone peer review. Studies subsequent to the IARC study have 
corroborated that study's findings that there is a correlation between 
melanoma and sunlamp product use. For example, a meta-analysis 
employing data from numerous studies found an increased risk of 
melanoma with sunlamp product use (Ref. 17). Furthermore, this study 
noted that the magnitude of the increased risk was greater when sunlamp 
product use began earlier in life. In addition, Dor[eacute] and Chignol 
observed that two studies in Minnesota and Australia found an increased 
risk of melanoma with indoor tanning (Ref. 18). They also observed a 
very large study of Norwegian and Swedish women that found an increased 
risk of melanoma with indoor tanning.
    (Comment 28) After further analysis of the IARC report, Dr. Mia 
Papas and Dr. Anne Chappelle published a peer-reviewed report (Ref. 19) 
criticizing the IARC report for not differentiating among Medical 
Phototherapy Equipment, Unsupervised Home Equipment, and Commercial 
Tanning Salon Equipment. Their article indicates that there is no 
association between sunlamp product use and melanoma if you remove home 
use and medical use of sunlamp products from the analysis. Therefore, 
the report being used to support the reclassification is flawed.
    (Response 28) This literature (Ref. 19) has not been published in a 
peer-reviewed journal, despite the commenter's assertion to the 
contrary. In the peer-reviewed journal ``Cancer Epidemiology, 
Biomarkers & Prevention,'' Gallagher et al. (Ref. 16) noted that the 
results from studies subsequent to the IARC report, taken together, do 
not differ in character from those seen in the earlier studies. During 
earlier studies, home use of sunlamp products was greater than it is 
now. During later studies, the proportion of the sunlamp product use at 
indoor tanning facilities increased greatly, but according to Gallagher 
et al. (Ref. 16), melanoma incidence did not markedly differ, 
supporting the conclusion that the risk from use of sunlamp products at 
tanning facilities does not differ markedly from the risks of home use 
of such devices.
    (Comment 29) An article written by William Grant (Ref. 20) 
indicated that the 50 subjects in the IARC report were primarily skin 
type 1. Skin type 1 individuals have a natural increased risk to skin 
cancer and because tanning facilities do not tan skin type 1's, this 
skewed the data in the IARC report.
    (Response 29) The Grant critique (Ref. 20) points out that fair 
skinned individuals are more likely than other individuals to develop 
skin cancer due to UV exposure. However, UV radiation exposure from 
indoor tanning use increases the risk of skin cancer regardless of 
whether individuals have high or low pigmentation (Ref. 21). For this 
reason, FDA has not changed its position regarding the link between 
sunlamp product use and skin cancer. It is also important to note that 
a significant portion of the U.S. population is skin type 1 and may use 
sunlamp products (Ref. 22).

F. Miscellaneous

    (Comment 30) Unless tanning beds for home use are banned, this 
reclassification does not make sense.
    (Response 30) The commenter did not provide a justification for 
this conclusion, so we are not completely clear as to the basis for 
this comment. However, we emphasize that the new 510(k) requirements 
and special controls (including labeling) set forth in this final order 
apply to all sunlamp products and UV lamps intended to be used in 
sunlamp products, including ones sold to individuals for home use. FDA 
believes that the regulatory controls set forth in this order are 
necessary to provide a reasonable assurance of safety and effectiveness 
for these devices.
    (Comment 31) Regulated tanning facilities are a safer alternative 
than home tanning where there are no informed workers. Tanning facility

[[Page 31212]]

owners are trained and educated to protect clients who want to tan.
    (Response 31) This final order does not distinguish between devices 
sold for use at home and devices sold to tanning facilities; the 
regulatory controls set forth in this order apply to both.
    (Comment 32) People who have prescriptions for dermatological 
disorders will be burdened by this reclassification.
    (Response 32) Devices prescribed for individuals with 
dermatological disorders have been and will continue to be regulated 
differently from devices regulated under Sec.  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.

III. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings 
as published in the preamble to the proposed order. FDA is issuing this 
final order to reclassify UV lamps used to tan the skin from class I 
(general controls) exempt from premarket notification to class II 
(special controls) and subject to premarket notification and rename 
them sunlamp products and UV lamps intended for use in sunlamp 
products.

IV. Premarket Notification

    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 reclassification, the Agency is not exempting 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 predicate devices already legally on 
the market will be subject to the more rigorous premarket approval 
requirement.
    FDA cleared several 510(k)s for sunlamp products prior to exempting 
the devices from premarket notification submission.\3\ 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.
---------------------------------------------------------------------------

    \3\ See 59 FR 63005 (December 7, 1994).
---------------------------------------------------------------------------

V. Implementation Strategy

    Based on comments on the proposed order regarding our 
implementation strategy, we are clarifying the compliance dates for the 
various requirements set forth in this final order. For additional 
information on this issue, see the DATES heading of this final order.
     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 Sec.  807.81(a)(3) because the device is 
about to be significantly changed or modified: \4\ Manufacturers must 
obtain 510(k) clearance before marketing the new or changed device.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

     Models of sunlamp products and UV lamps intended for use 
in sunlamp products that have been offered for sale prior to September 
2, 2014, and continue to be offered for sale after this date: 
Manufacturers must submit a 510(k) and comply with labeling special 
controls by August 26, 2015, for any device they wish to continue 
offering for sale. If a 510(k) is not submitted by this date or the 
device is not in compliance with the labeling special controls or if 
FDA determines after review of the 510(k) that either the device is not 
substantially equivalent to a legally marketed predicate or the device 
is not in compliance with the labeling or other special controls, the 
device model would be adulterated and misbranded, and offering the 
device for sale would have to cease.
     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 Sec.  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.

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this 
reclassification action is of a type that does not individually or 
cumulatively have a significant effect on the human environment. 
Therefore, neither an environmental assessment nor an environmental 
impact statement is required.

VII. Paperwork Reduction Act of 1995

    This final order refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in part 807, subpart E, have been 
approved under OMB control number 0910-0120 and the collections of 
information under 21 CFR part 801 have been approved under OMB control 
number 0910-0485.
    In addition, FDA concludes that the labeling statements in Sec.  
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)).

VIII. Codification of Orders

    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

[[Page 31213]]

Sec.  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.

IX. References

    FDA has placed the following references on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. Interested persons may see 
them between 9 a.m. and 4 p.m., Monday through Friday, and online at 
http://www.regulations.gov. (FDA has verified all the Web site 
addresses in this reference section, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

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.
7. 78 FR 27117, May 9, 2013.
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&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. Dor[eacute], 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&rct=j&q=&esrc=s&source=web&cd=1&ved=0CCkQFjAA&url=http%3A%2F%2Ftancanada.org%2Fwp-content%2Fuploads%2F2013%2F05%2Fsuntan_poster_4-final-Montreal.pdf&ei=u8B8U7iiFdbesATr7oGoCA&usg=AFQjCNFNmLHAAiGcthuPeFfKj94zhexEaw&sig2=IZO-wr4jPtD8ql5fvhV7Vg&bvm=bv.67229260,d.cWc&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.

List of Subjects in 21 CFR Part 878

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Section 878.4635 is revised to read as follows:


Sec.  878.4635  Sunlamp products and ultraviolet lamps intended for use 
in sunlamp products.

    (a) Identification. A sunlamp product is any device designed to 
incorporate one or more ultraviolet (UV) lamps intended for irradiation 
of any part of the living human body, by UV radiation with wavelengths 
in air between 200 and 400 nanometers, to induce skin tanning. This 
definition includes tanning beds and tanning booths. A UV lamp intended 
for use in sunlamp products is any lamp that produces UV radiation in 
the wavelength interval of 200 to 400 nanometers in air.
    (b) Classification. Class II (special controls). The special 
controls for sunlamp products and UV lamps intended for use in sunlamp 
products are:
    (1) Conduct performance testing that demonstrates the following:
    (i) Device meets appropriate output performance specifications such 
as wavelengths, energy density, and lamp life; and
    (ii) Device's safety features, such as timers to limit UV exposure 
and alarms, function properly.
    (2) Demonstrate that device is mechanically safe to prevent user 
injury.
    (3) Demonstrate software verification, validation, and hazard 
analysis.
    (4) Demonstrate that device is biocompatible.
    (5) Demonstrate that device is electrically safe and 
electromagnetically compatible in its intended use environment.
    (6) Labeling--(i) Sunlamp products. (A) The warning statement below 
must appear on all sunlamp products and must be placed in a black box. 
This statement must be permanently affixed or inscribed on the product 
when fully assembled for use so as to be legible and readily accessible 
to view by the person who will be exposed to UV radiation immediately 
before the use of the product. It shall be of sufficient durability to 
remain legible throughout the expected lifetime of the product. It 
shall appear on a part or panel displayed prominently under normal 
conditions of use so that it is readily accessible to view whether the 
tanning bed canopy (or tanning booth door) is

[[Page 31214]]

open or closed when the person who will be exposed approaches the 
equipment and the text shall be at least 10 millimeters (height). 
Labeling on the device must include the following statement:

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Attention: This sunlamp product should not be used on persons under the
 age of 18 years.
------------------------------------------------------------------------

    (B) Manufacturers shall provide validated instructions on cleaning 
and disinfection of sunlamp products between uses in the user 
instructions.
    (ii) Sunlamp products and UV lamps intended for use in sunlamp 
products. Manufacturers of sunlamp products and UV lamps intended for 
use in sunlamp products shall provide or cause to be provided in the 
user instructions, as well as all consumer-directed catalogs, 
specification sheets, descriptive brochures, and Web pages in which 
sunlamp products or UV lamps intended for use in sunlamp products are 
offered for sale, the following contraindication and warning 
statements:
    (A) ``Contraindication: This product is contraindicated for use on 
persons under the age of 18 years.''
    (B) ``Contraindication: This product must not be used if skin 
lesions or open wounds are present.''
    (C) ``Warning: This product should not be used on individuals who 
have had skin cancer or have a family history of skin cancer.''
    (D) ``Warning: Persons repeatedly exposed to UV radiation should be 
regularly evaluated for skin cancer.''
    (c) Performance standard. Sunlamp products and UV lamps intended 
for use in sunlamp products are subject to the electronic product 
performance standard at Sec.  1040.20 of this chapter.

    Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12546 Filed 5-29-14; 11:15 am]
BILLING CODE 4160-01-P