Document ID: FDA-2013-N-0461-0001
Agency: fda
Document Type: Proposed Rule
Title: General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products
Posted Date: 2013-05-09T04:00Z

[Federal Register Volume 78, Number 90 (Thursday, May 9, 2013)]
[Proposed Rules]
[Pages 27117-27124]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10982]

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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed Order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify 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 to rename 
them sunlamp products. FDA is also designating special controls that 
are necessary to provide a reasonable assurance of the safety and 
effectiveness of the device. FDA is proposing this reclassification on 
its own initiative based on new information.

DATES: Submit either electronic or written comments on this proposed 
order by August 7, 2013. See section XI for the proposed effective date 
of a final order based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0461, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-0461. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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, unlike the 
administrative order procedures that apply to this proposed 
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 (some remain unclassified).
    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.

[[Page 27118]]

Those devices remain in class III and require premarket approval 
unless, and until, the device is classified or reclassified into class 
I or II under section 513(f)(2) or (3) of the FD&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.)
    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 (DC 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 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, including sunlamp products. 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 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 manufactured on or after September 8, 1986. FDA 
plans to propose amendments to this performance standard to reflect 
current scientific knowledge related to sunlamp use, harmonize it more 
closely with International Electrotechnical Commission (IEC) 
International Standard 60335-2-27, Ed. 5.0: 2009-12, and strengthen the 
warning statement required by 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 (Public Law 110-85).

II. Regulatory History of the Device

    In a 1977 report, the General and Plastic Surgery Device 
Classification Panel and the Physical Medicine Device Classification 
Panel (the Panels) recommended that dermatologic UV lamps (devices that 
provide UV radiation intended primarily for the treatment of 
dermatologic disorders or for tanning) be classified into class II (see 
47 FR 2810 at 2835; January 19, 1982).
    The Panels recommended that dermatologic UV lamps be classified 
into class II because the Panels believed that the electrical and 
optical properties of the device must be controlled to prevent 
electrical shock, overexposure because of timer malfunction, and burns 
to eyes and skin. The Panels believed that general controls would not 
be sufficient to provide a reasonable assurance of safety and 
effectiveness, and that a performance standard would provide reasonable 
assurance of the safety and effectiveness of the device. The Physical 
Medicine Device Classification Panel also recommended that the device 
be sold only by prescription. The Panels identified the following risks 
to health for these devices:
    1. Burns to skin and eyes: Improper shielding of eyes or 
overexposure of UV radiation to skin may result in burns. Also, 
excessive UV, visible, and infrared radiation from this device can be 
harmful to the eyes and skin.
    2. Aging of skin: Excessive exposure to UV radiation may result in 
premature aging of skin.
    3. Skin cancer: Excessive irradiation of the skin with UV lamps is 
correlated with increased incidence of skin cancer.
    4. Photosensitivity: Exposure of patients with photosensitive skin 
to UV radiation may induce photosensitivity reactions.
    FDA agreed with the Panels' recommendations and proposed that these 
devices be classified into class II in a proposed rule published in the 
Federal Register on January 19, 1982. However, in its final rule, 
published on June 24, 1988 (53 FR 23856 at 23868), FDA separated UV 
lamps for dermatological disorders and UV lamps for tanning. It 
classified the former in class II under 21 CFR 878.4630, but postponed 
classification of UV lamps for tanning in order to consider electrical 
safety information and to consider issuing a proposal to classify UV 
lamps for tanning in class I. FDA explained that the performance 
standard for sunlamp products at Sec.  1040.20 addressed the risks to 
health presented by UV lamps for tanning other than electrical safety 
hazards. On November 15, 1988 (53 FR 46040), FDA proposed that 70 
electromedical devices, including UV lamps for tanning, be classified 
in class I; FDA finalized this classification on November 20, 1990 (55 
FR 48436 at 48440).
    On December 7, 1994, FDA amended the classification when it 
published a final rule in the Federal Register (59 FR 63005) that 
exempted 148 class I devices from premarket notification (with 
limitations), including UV lamps for tanning. FDA determined that 
manufacturers' submissions of premarket notifications for UV lamps for 
tanning were not necessary for the protection of the public health at 
that time. Prior to the issuance of the 1994 final rule exempting UV 
lamps for tanning from premarket notification submission, some 
manufacturers of UV lamps for tanning had already submitted 510(k)s and 
received clearance for their devices, and at least one 510(k) for a 
sunlamp product has been cleared since then. As discussed further in 
this document, these devices may serve as

[[Page 27119]]

predicate devices for future 510(k)s if this order is finalized. On 
July 25, 2001, FDA made a technical amendment to the classification of 
UV lamps for tanning to state that the exemption from 510(k) is subject 
to the limitations in 21 CFR 878.9 (66 FR 38786 at 38803).

III. Device Description

    The current device classification regulation for this product 
refers to it as an ``ultraviolet lamp for tanning,'' while the current 
electronic product performance standard for this product refers to it 
as a ``sunlamp product.'' Because both of these regulations describe 
the same product with the same intended use for tanning, FDA proposes 
to rename the device in this regulation for purposes of consistency and 
clarity. FDA proposes to identify this device as a ``sunlamp product'': 
An electronic product that includes one or more UV lamps and a fixture 
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, tanning 
booths, and UV lamps (bulbs) sold separately.

IV. Summary of Valid Scientific Evidence Concerning Reclassification

A. Public Health Benefit From Use of the Device

    It is well recognized that sunlamp products are effective at 
producing a tan or darkening of the skin (except in very light skin 
individuals, who may burn instead of tan); and this is perceived by 
users as an aesthetic benefit. One study reported that 47 percent of 
college students had reported using a sunlamp product during the last 
year because it improved their appearance, despite 92 percent being 
aware of potential health risks (Ref. 1). Investigators have also 
looked at the effect of sunlamp products on mood to treat depression 
and/or seasonal affective disorder (SAD). The general therapeutic 
effect of visible light on SAD has been widely acknowledged (Ref. 2). 
However, there is no definitive evidence that UV radiation is effective 
in the treatment of SAD (Refs. 2 and 3).
    Vitamin D has been the focus of recent research due to the 
possibility that it could help prevent some cancers and provide other 
health benefits (besides the well-recognized effect of contributing to 
bone health and preventing rickets). Some sunlamp products can produce 
Vitamin D (Ref. 4), but to date, it is unclear whether the benefit of 
such production outweighs the risks of use. A meta-analysis by Woo and 
Eide in 2010 (Refs. 5 and 6) supported the consensus medical and public 
health opinion that dietary supplements are safer than and as 
beneficial as tanning to produce Vitamin D. Furthermore, most people 
meet at least some of their Vitamin D needs through exposure to 
sunlight in moderate dosages. The World Health Organization (WHO) has 
stated that ``While sunbed use may increase vitamin D synthesis, * * * 
if people require more vitamin D than the sun can provide (for example, 
because of living in polar regions) this should be supplemented through 
diet rather than sunbed use'' (Ref. 7). A minority of researchers have 
argued that the potential benefit of sunlamp products might outweigh 
the health risks (Refs. 8 and 9).
    Proponents of sunlamp products have also claimed that the use of 
sunlamp products may be helpful in promoting a base tan--a tan that 
prevents sunburns. However, a base tan, either from the sun or from 
sunlamp products, provides minimal protection against burning, and 
there is no evidence that a base tan provides any protection against 
premature aging of the skin or reduces the risk of skin cancer 
(cumulative UV exposure is likely to increase rather than decrease the 
risk of skin cancer) (Ref. 10).

B. Risks Posed by the Device

    As stated previously, the original classification panels identified 
four risks to health associated with UV lamps. After considering the 
deliberations of the original reclassification panels mentioned in this 
document, the deliberations of a March 2010 General and Plastic Surgery 
Advisory Panel meeting on UV lamps for tanning, and published 
literature, FDA has determined that the risks to health listed in this 
document are associated with sunlamp products. The proposed special 
controls and forthcoming proposed amendments to the performance 
standard address these risks:
    1. Increased Skin Cancer Risk From Cumulative Repeated UV Radiation 
Exposure: UV radiation exposure can lead to permanent damage to DNA in 
the skin, which has been shown to lead to an increased risk of skin 
cancer (Refs. 11 and 12). Skin cancers that have been associated with 
cumulative repeated UV radiation exposure include melanoma and non-
melanoma skin cancers such as basal cell carcinoma and squamous cell 
carcinoma (Ref. 13). The risk may be higher in certain individuals with 
fairer, less pigmented skin, but can also be elevated in other 
individuals (Ref. 14). In addition to users with a personal history of 
melanoma having an increased risk of skin cancer, users with familial 
melanoma are also at increased risk for skin cancer--having one first-
degree relative with melanoma doubles the risk of melanoma (Refs. 15 
and 16). As with other radiation exposure, increased cumulative 
lifetime exposure results in increased skin cancer risk (for both 
melanoma and non-melanoma skin cancer) (Ref. 17).
    There is increasing epidemiological evidence that tanning in 
childhood to early adult life increases the rate of melanoma (Refs. 18 
and 19). Melanoma (of the two categories of skin cancer, this is the 
more concerning type due to greater potential for fatality) is 
currently the second leading type of cancer in young adults, and many 
experts believe that at least one cause for this is the increasing use 
of sunlamp products by this population (Ref. 20). FDA is also concerned 
that youths and adolescents may fail to appreciate the long-term 
dangers of sunlamp products (Refs. 21 and 22). The WHO has classified 
UV radiation from sunlamps as a class I carcinogen based on a 2009 
International Agency for Research in Cancer (IARC) report that linked 
tanning bed use by individuals under age 35 to higher rates of melanoma 
and recommended that minors not use indoor tanning equipment (Ref. 23). 
This concern has led several states and one county in the United 
States, and several foreign governments, to ban the use of sunlamps by 
minors under a certain age (Refs. 24 and 25).
    2. Ocular Injury: UV and visible radiation from this device can be 
harmful to the eyes if proper protective eyewear is not worn.\1\ The 
intense light from sunlamps can cause keratitis and corneal burns, 
which can be painful and affect vision (Ref. 26). Artificial UV 
radiation has also been recently linked to ocular melanoma, which can 
cause vision loss and often spreads to other parts of the body (Ref. 
27).
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    \1\ Ocular risks are addressed by labeling and performance 
requirements regarding eyewear at Sec.  1040.20.
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    3. Discomfort, Pain, and Tenderness on the Skin Resulting From 
Burns to the Skin due to Acute Overexposure to UV Radiation: A recent 
evaluation showed that, despite protective measures instituted in 
commercial tanning facilities, 66 percent of female college-age users 
reported skin erythema (or redness due to sunburn) from indoor tanning, 
and these users reported one episode of sunburn out of every five 
tanning sessions (Ref. 28). Those findings are in line with a previous 
report that 58 percent of adolescent

[[Page 27120]]

tanning bed users had experienced sunburns from exposure to sunlamps 
(Ref. 29). In certain individuals who are photosensitive, skin exposure 
to UV radiation may induce unexpected reactions such as rash, severe 
burns, and hypersensitivity reactions (Ref. 30). Sunlamps, like most 
light sources, also generate heat that can cause thermal skin burns, 
similar to any hot surface. Individuals with open wounds or lesions are 
particularly susceptible to burns from UV light because those 
individuals lack the protective epidermal layer of the skin that 
provides the body's greatest protection from UV irradiation (Ref. 31).
    4. Skin Damage: Cumulative, repeated exposure to UV radiation 
emitted by sunlamps may lead to accelerated aging of skin due in part 
to DNA and skin cell damage (Ref. 32). UV irradiation inhibits the 
production of collagen precursor molecules such as type I and type III 
procollagen (Ref. 33). UV irradiation stimulates skin 
metalloproteinases, which break down skin proteins that then lead to 
photoaging (Ref. 34). On a cellular level, UV radiation has been known 
to cause DNA damage through formation of thymidine cyclobutane dimers 
and via oxidative damage as a result of UV generated superoxide 
radicals (Ref. 11).
    5. Lack of Biocompatibility: Device materials that are not 
biocompatible may, either directly or through the release of their 
material constituents, (i) Produce adverse local or systemic effects, 
(ii) be carcinogenic, or (iii) produce adverse reproductive and 
developmental effects. Although medical devices may have myriad 
biocompatibility issues (Ref. 35), the biocompatibility concerns from 
sunlamp products are likely limited to inflammatory skin reactions from 
contact with the materials from which the bed is made.
    6. Transmission of Infectious Diseases Due to Improper Cleaning and 
Disinfection: This is a concern for any reusable device. Sunlamp 
products in an indoor tanning facility may be shared by dozens of users 
in a single day. Cleaning and disinfection practices, as well as 
training by facility operators, may vary from facility to facility. 
Because sunlamp product users directly contact the device with their 
skin, users with open wounds or lesions have the potential to transmit 
infectious diseases to subsequent users if the device is not properly 
disinfected between users.
    7. Electrical Shock: Electrical shock hazards can pose a potential 
hazard to both operators and users. These are commonly caused by 
manufacturing defects or are the result of frequent use (e.g., frayed 
wiring and broken connectors) (Ref. 36).
    8. Mechanical Injury: Sunlamp products can pose a threat of blunt 
force injury or entrapment of a user due to the heavy and bulky nature 
of some of these devices and the fact that users are completely inside 
a tanning bed or booth during use. Such injuries and entrapment may 
result from manufacturing defects and may be exacerbated by frequent 
use.
    9. Use Error: All of the risks discussed in this document may be 
exacerbated by human error. Human error can include misuse by the 
individual using the sunlamp to obtain a tan, including not wearing the 
correct eye protection, setting the exposure timer for longer than the 
recommended time in the exposure schedule for the individual's skin 
type or skin acclimatization, use by individuals who should not be 
exposed to the sunlamp, and not following the warnings and cautions. 
Use error also includes errors by the sunlamp product operator (for 
example, if used at an indoor tanning facility). These would include 
improper maintenance of fixtures leading to electrical shock or 
contaminated bed surfaces, improper maintenance or selection of lamps 
leading to overexposure, and incorrect use of timer according to 
recommended exposure schedule.

V. 2010 Classification Panel Meeting

    On March 25, 2010, FDA held a General and Plastic Surgery Advisory 
Panel meeting on UV lamps for tanning (Ref. 37). The Panel reviewed and 
discussed recent information, including recent literature regarding the 
possible risks to the general public from intentional exposure to 
sunlamp products.
    There is a growing body of literature showing an association of 
skin cancer with use of sunlamp products (Refs. 38 to 53), and the 
Panel discussed this information and other information related to the 
association of UV and skin cancer (both melanoma and non-melanoma) 
(Ref. 36). The Panel discussed whether changes to the current 
classification or current regulatory controls of UV-emitting devices 
(lamps) used for tanning are needed. The Panel generally agreed that 
stricter FDA regulation of these devices is necessary to control the 
serious risks they pose and unanimously agreed that the device should 
not be a class I device. No significant changes in risks relating to 
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.
    The following summarizes some of the Panel members' responses to 
the questions posed and the Panel members' views related to a variety 
of measures that may be necessary to provide a reasonable assurance of 
safety and effectiveness:
     Regarding reclassification, there was general Panel 
consensus that UV lamps for tanning should not be class I devices. The 
Panel, however, appeared to be split on whether UV lamps for tanning 
should be reclassified into class III or class II in light of the risks 
they pose. Some Panel members believed that UV lamps for tanning should 
be reclassified into class III. Other Panel members recommended that UV 
lamps for tanning be classified as class II, and felt that special 
controls and/or restrictions related to, for example, age, skin type, 
and cancer risk, would mitigate the risks associated with the use of 
these devices and would provide a reasonable assurance of safety and 
effectiveness. A few Panel members discussed banning UV lamps for 
tanning. No Panel member recommended leaving these devices in class I.
     Regarding the user's age, some Panel members favored an 
age restriction for indoor tanning (i.e., individuals under a certain 
age would not be permitted to use UV lamps for tanning), and agreed 
that the cutoff age should be 18.
     Some Panel members recommended that individuals with a 
genetic predisposition or family history of skin cancer should be 
subject to special restrictions (e.g., education requirements) prior to 
using UV lamps for tanning because they were at a greater risk for 
developing skin cancer than the general population.
     Some Panel members recommended that users of UV lamps for 
tanning should have to read a form disclosing the risks related to UV 
lamps for tanning and acknowledge receipt of this information in 
writing prior to using the device. Panel discussion points for the 
disclosure of risk form related to topics such as genetic history, past 
history of melanoma, and usage in pregnancy. Some Panel members also 
supported more prominent posting of risks and warnings.
    Docket No. FDA-2009-N-0606 was opened to receive comments on the 
regulation of sunlamp products (75 FR 1395; January 11, 2010). The 
majority of the input received via the open public docket supported 
strengthening FDA's regulation of these devices. Although many comments 
did not expressly

[[Page 27121]]

specify whether regulation of sunlamps should be strengthened or not, 
because most of these were related to the experiences of people with 
melanoma, FDA interpreted them to be in support of stricter regulation 
of sunlamps. Six comments of 139 total comments took the position that 
FDA should not change its current regulation of indoor tanning devices. 
Overall, the docket comments strongly paralleled the opinions of the 
Panel members.

VI. Proposed Reclassification

    Based on the comments from the 2010 reclassification panel, the 
comments received in the docket, and FDA's assessment of new, valid 
scientific data related to the health benefits and risks associated 
with sunlamp products, FDA is proposing that sunlamp products be 
reclassified from class I (general controls) to class II (special 
controls) because general controls alone are insufficient to provide 
reasonable assurance of safety and effectiveness, and there is 
sufficient information to establish special controls to provide such 
assurance. FDA is not proposing to classify these devices in class III 
at this time because special controls can provide a reasonable 
assurance of safety and effectiveness.
    The proposed special controls for this device--identified as 
follows (and underlined)--are necessary to provide a reasonable 
assurance of safety and effectiveness for this device. Failure to 
comply with the special controls that are included in a final order 
would cause a sunlamp product to fall outside this classification, and 
thus be classified in class III. Failure to obtain premarket approval 
of a class III device prior to marketing causes the device to be 
adulterated under section 501(f) of the FD&C Act (21 U.S.C. 351(f)).
    (1) Conduct performance testing that demonstrates the following:
    i. Sunlamp products meet appropriate output performance 
specifications such as wavelengths, energy density, and lamp life; and
    ii. Safety features, such as timers to limit UV exposure and 
alarms, function properly.
    Performance testing would have to demonstrate the appropriateness 
of sunlamp product output performance specifications, that the device 
performs within such specifications, and proper functioning of safety 
features such as timers and alarms. This requirement would mitigate the 
risks of skin cancer, discomfort, pain, and tenderness resulting from 
burns to the skin due to acute and/or cumulative overexposure to UV 
radiation, and skin damage by providing assurance that the output of 
the device is as expected and within appropriate parameters, and users 
are not unintentionally exposed to excessive radiation.
    All performance testing and results must also be in conformance 
with the performance standard at Sec.  1040.20.
    (2) Demonstrate that sunlamp products are mechanically safe to 
prevent user injury.
    Mechanical safety testing, such as cyclic fatigue testing and 
strength and materials testing, would help to ensure that the device's 
mechanical features can withstand multiple uses and are sufficiently 
durable so as not to injure users in the event of a failure of a 
mechanical feature.
    (3) Demonstrate software verification, validation, and hazard 
analysis.
    Appropriate software verification, validation, and hazard analysis 
would help to ensure that the software-controlled device functions 
(such as the timer, alarms, and basic functions like powering on and 
off) are in proper working order. This requirement would mitigate 
increased skin cancer risk from cumulative repeated UV radiation 
exposure, discomfort, pain, and tenderness resulting from burns to the 
skin due to acute overexposure to UV radiation, skin damage, and use 
error by helping to ensure a proper software/user interface and that 
proper instructions are provided to the operator in software outputs.
    (4) Demonstrate that sunlamp products are biocompatible.
    The biocompatibility of sunlamps would have to be demonstrated. 
Sunlamp products contact users' skin directly; therefore, a 
demonstration of biocompatibility would mitigate the risks of adverse 
local or systemic effects such as skin inflammation.
    (5) Demonstrate that sunlamp products are electrically safe and 
electromagnetically compatible in their intended use environment.
    The requirement to demonstrate electrical safety would mitigate the 
risks of electrical shock hazards for sunlamp product operators and 
users. The requirement to demonstrate electromagnetic compatibility 
would, in concert with other special controls, help ensure the 
mitigation of discomfort, pain, and tenderness resulting from burns to 
the skin due to acute overexposure to UV radiation by preventing 
electromagnetic interference with sunlamp hardware and software.
    (6) Labeling must bear all information required for the reasonable 
assurance of safe and effective use of the device. (Please see proposed 
21 CFR 878.4635(b)(6)).
    These labeling requirements would help to discourage use of sunlamp 
products by those populations that are especially susceptible to the 
risk of skin cancer--persons under the age of 18 and persons with a 
prior personal history or family history of skin cancer. When combined 
with the labeling requirements of the sunlamp performance standard in 
Sec.  1040.20, this labeling would help clearly communicate the risks 
of skin cancer to all users. A warning directing users of this device 
who are repeatedly exposed to sunlamp products to be regularly 
evaluated for skin cancer would help to clearly communicate the 
increased risk of skin cancer from cumulative UV radiation exposure and 
help to mitigate that increased risk. Clear communication of these 
risks and identification of susceptible populations would help 
potential users make an informed choice about use of sunlamp products 
and mitigate the increased risk of skin cancer from cumulative UV 
radiation exposure in all users by encouraging judicious use of these 
devices. This labeling would also help to mitigate other risks of use 
of sunlamp products, including discomfort, pain, and tenderness 
resulting from burns to the skin due to acute overexposure to UV 
radiation.
    Transmission of infectious diseases due to improper cleaning and 
disinfection would be mitigated through the requirement to provide 
instructions for cleaning and disinfection of the device that have been 
validated for use with the sunlamp product they accompany, and a 
warning that the device not be used if skin lesions or open wounds are 
present. The contraindication against use if skin lesions or open 
wounds are present would also help to mitigate the risk of discomfort, 
pain, and tenderness resulting from burns to the skin due to acute 
overexposure to UV radiation by discouraging users who are particularly 
susceptible to this risk due to a lack of critical epidermal protection 
from using sunlamp products.
    The requirement to provide labeling that contains all necessary 
information for safe and effective use of a sunlamp product would help 
mitigate use error as well as ocular injury by instructing users to 
wear protective UV eyewear at all times when using the device.

VII. 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 proposed reclassification, the Agency does not propose to exempt

[[Page 27122]]

these devices from premarket notification (510(k)) submission 
requirements as provided for under section 510(m) of the FD&C Act. The 
premarket notification requirement allows the Agency to review the 
technological characteristics, performance, intended use(s), and 
labeling of medical devices to ensure the devices are substantially 
equivalent to legally marketed predicate devices before they enter the 
market. Substantial equivalence requires that a new device must have 
(1) the same intended use as legally marketed predicates, and (2) 
either the same technological characteristics as a legally marketed 
predicate, or if there are significant differences, the differences 
must not raise new questions of safety and effectiveness and the 
performance data must demonstrate that the new device is at least as 
safe and effective as the legally marketed predicate device. (See 
section 513(i) of the FD&C Act.) This assures that new devices that 
differ significantly in terms of safety and effectiveness from devices 
already legally on the market will be subject to the more rigorous 
premarket approval requirement.
    As discussed previously, FDA cleared several 510(k)s for sunlamp 
products prior to the issuance of the 1994 final rule exempting them 
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 can serve as predicates for substantial 
equivalence purposes.

VIII. Implementation Strategy

    FDA is proposing the implementation strategy as follows regarding 
510(k) submission and special controls compliance:
     Sunlamp product models that have not been marketed prior 
to the effective date of a final order based on this proposal, or have 
been marketed but are required to submit a new 510(k) under Sec.  
807.81(a)(3) because the device is about to be significantly changed or 
modified: \2\ FDA would expect manufacturers of these devices to obtain 
510(k) clearance and comply with all special controls before marketing 
the new or changed device.
---------------------------------------------------------------------------

    \2\ See FDA's guidance, ``Deciding When to Submit a 510(k) for a 
Change to an Existing Device,'' (available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm), for additional guidance on whether a device change 
or modification requires a 510(k) submission.
---------------------------------------------------------------------------

     Sunlamp product models that have been marketed prior to 
the effective date of a final order based on this proposal: FDA would 
expect manufacturers to either submit a 510(k) and comply with all 
special controls within 1 year of the effective date of a final order, 
or cease marketing that model. During the 1 year following the 
effective date of the final order, FDA intends to exercise enforcement 
discretion while manufacturers prepare and submit their 510(k). FDA 
would expect sunlamp products marketed during the 1 year period to 
comply with all special controls by the time the period expires.
     Individual sunlamp products that have been shipped to 
operators or users such as salons and individual consumers before the 
effective date of a final order: FDA would expect manufacturers to 
provide updated labeling that complies with the labeling special 
controls in proposed Sec.  878.4635(b)(6) (21 CFR 878.4635(b)(6)) to 
operators or users within 1 year of the effective date of a final 
order.

IX. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this proposed 
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.

X. Paperwork Reduction Act of 1995

    This proposed 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 proposed 
Sec.  878.4635(b)(6)(i), (b)(6)(iii), and (b)(6)(iv) do not constitute 
a ``collection of information'' under the PRA. Rather, the labeling 
statements are ``public disclosure of information originally supplied 
by the Federal government to the recipient for the purpose of 
disclosure to the public.'' (5 CFR 1320.3(c)(2)).

XI. Proposed Effective Date

    FDA proposes that any final administrative order based on this 
proposal become effective 90 days after its date of publication in the 
Federal Register. Please see section VIII, ``Implementation Strategy,'' 
for projected dates by which FDA will expect 510(k) submissions and 
conformance to special controls.

XII. Comments

    Interested persons may submit either electronic comments regarding 
this order to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). FDA is explicitly 
seeking comment on the following issues:
     Whether FDA should consider additional special controls or 
other regulatory requirements to mitigate the risks posed by sunlamp 
products.
     FDA's proposed implementation strategy. In particular, 
what is the most practical method for manufacturers of devices 
currently on the market to conform to the labeling special control in 
proposed Sec.  878.4635(b)(6) before 1 year after the effective date of 
the final order?
    It is necessary to send only one set of comments. Identify comments 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m. Monday through Friday, and will be 
posted to the docket at http://www.regulations.gov.

XIII. 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 proposed order, we are proposing to revoke the 
requirements in Sec.  878.4635 related to the classification of UV 
lamps for tanning as class I devices and to codify the reclassification 
of sunlamp products into class II.

XIV. References

    FDA has placed the following references on display in the Division 
of Dockets Management (see ADDRESSES). 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

[[Page 27123]]

reference section, but we are not responsible for any subsequent 
changes to the Web sites after this document publishes in the Federal 
Register.)

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``Awareness of the Risks of Tanning Lamps Does Not Influence 
Behavior Among College Students,'' Archives of Dermatology, vol. 
138, pp. 1311-1315, 2002.
    2. Lam, R.W., A. Buchanan, J.A. Mador, et al., ``The Effects of 
Ultraviolet-A Wavelengths in Light Therapy for Seasonal 
Depression,'' Journal of Affective Disorders, vol. 24, pp. 237-243, 
1992.
    3. Lee, T.M., C.C. Chan, J.G. Paterson, et al., ``Spectral 
Properties of Phototherapy for Seasonal Affective Disorder: A Meta-
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1997.
    4. Devgun, M.S., B.E. Johnson, and C.R. Paterson, ``Tanning, 
Protection Against Sunburn and Vitamin D Formation With a UV-A `Sun-
Bed','' British Journal of Dermatology, vol. 107, pp. 275-284, 1982.
    5. Woo, D.K. and M.J. Eide, ``Tanning Beds, Skin Cancer, and 
Vitamin D: An Examination of the Scientific Evidence and Public 
Health Implications,'' Dermatologic Therapy, vol. 23, pp. 67-71, 
2010.
    6. National Institutes of Health, Office of Dietary Supplements, 
``Dietary Supplement Fact Sheet: Vitamin D,'' (http://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/).
    7. World Health Organization, ``Sunbeds, Tanning and UV 
Exposure,'' (http://www.who.int/mediacentre/factsheets/fs287/en/index.html).
    8. Giovannucci, E., Y. Liu, E.B. Rimm, et al., ``Prospective 
Study of Predictors of Vitamin D Status and Cancer Incidence and 
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    9. Cannell, J.J., B.W. Hollis, M. Zasloff, et al., ``Diagnosis 
and Treatment of Vitamin D Deficiency,'' Expert Opinion in 
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    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. Cadet, J., E. Sage, and T. Douki, ``Ultraviolet Radiation-
Mediated Damage to Cellular DNA,'' Mutation Research, vol. 571, pp. 
3-17, 2005.
    12. Fitzpatrick's Dermatology in General Medicine, 7th ed., p. 
999, Columbus, OH: McGraw-Hill, 2008.
    13. Ibid., p. 814.
    14. Ibid., p. 1135.
    15. 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.
    16. Niendorf, K.B. and H. Tsao, ``Cutaneous Melanoma: Family 
Screening and Genetic Testing,'' Dermatologic Therapy, vol. 19, pp. 
1-8, 2006.
    17. Nole, G. and A. Johnson, ``An Analysis of Cumulative 
Lifetime Solar Ultraviolet Radiation Exposure and the Benefits of 
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2004.
    18. 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.
    19. 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.
    20. Bleyer A. and R. Barr, ``Cancer in Young Adults 20 to 39 
Years of Age: Overview,'' Seminars in Oncology, vol. 36, pp. 194-
206, 2009.
    21. Beasley, M.T. and B.S. Kittel, ``Factors That Influence 
Health Risk Behaviors Among Tanning Salon Patrons,'' Evaluation & 
the Health Profession, vol. 20, pp. 371-388, 1997.
    22. Autier, P. and P. Boyle, ``Artificial Ultraviolet Sources 
and Skin Cancers: Rationale for Restricting Access to Sunbed Use 
Before 18 years of Age,'' Nature Reviews Clinical Oncology, vol. 5, 
pp. 178-179, 2008.
    23. ``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, 2009.
    24. National Conference of State Legislatures, ``Indoor Tanning 
Restrictions for Minors--A State by State Comparison,'' (http://www.ncsl.org/issues-research/health/indoor-tanning-restrictions.aspx). Updated April 2013.
    25. Pawlak, M.T., M. Bui, M. Amir, et al., ``Legislation 
Restricting Access to Indoor Tanning Throughout the World,'' 
Archives of Dermatology, vol. 148, pp. 1006-1012, 2012.
    26. Walters, B.L. and T.M. Kelley, ``Commercial Tanning 
Facilities: A New Source of Eye Injury,'' The American Journal of 
Emergency Medicine, vol. 5, pp. 386-389, 1987.
    27. Vajdic, C.M., A. Kricker, M. Giblin, et al., ``Artificial 
Ultraviolet Radiation and Ocular Melanoma in Australia,'' 
International Journal of Cancer, vol. 112, pp. 896-900, 2004.
    28. 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.
    29. 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.
    30. Fitzpatrick's Dermatology in General Medicine, 7th ed., p. 
828, Columbus, OH: McGraw-Hill, 2008.
    31. Ibid., p. 57.
    32. Ibid., p. 2353.
    33. Fisher, G.J., S. Kang, J. Varani, et al., ``Mechanisms of 
Photoaging and Chronological Skin Aging,'' Archives of Dermatology, 
vol. 138, pp. 1462-1470, 2002.
    34. Quan, T., Z. Qin, W. Xia, et al., ``Matrix-Degrading 
Metalloproteinases in Photoaging,'' Journal of Investigatory 
Dermatology Symposium Proceedings, vol. 14, pp. 20-24, 2009.
    35. Helmus, M.N., D.F. Gibbons, and D. Cebon, 
``Biocompatibility: Meeting a Key Functional Requirement of Next-
Generation Medical Devices,'' Toxicologic Pathology, vol. 36, pp. 
70-80, 2008.
    36. Olson, W.H., ``Electrical Safety,'' Medical Instrumentation 
Application and Design, 4th ed., Webster, J.G., ed., Hoboken, NJ: 
Wiley, 2009.
    37. FDA, 2010 Meeting materials, including presentations, a 
meeting transcript, and meeting summary, (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm205684.htm).
    38. FDA, ``Executive Summary,'' (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM205687.pdf).
    39. Autier, P., J.F. Dor[eacute], F. Lejeune, et al., 
``Cutaneous Malignant Melanoma and Exposure to Sunlamps or Sunbeds: 
An EORTC Multicenter Case-Control Study in Belgium, France and 
Germany. EORTC Melanoma Cooperative Group,'' International Journal 
of Cancer, vol. 58, pp. 809-813, 1994.
    40. Berwick, M., ``Are Tanning Beds 'Safe'? Human Studies of 
Melanoma,'' Pigment Cell & Melanoma Research, vol. 21; pp. 517-519, 
2008.
    41. Boyd, A.S., Y. Shyr, and L.E. King, Jr., ``Basal Cell 
Carcinoma in Young Women: An Evaluation of the Association of 
Tanning Bed Use and Smoking,'' Journal of the American Academy of 
Dermatology, vol. 46, pp. 706-709, 2002.
    42. Clough-Gorr, K.M., L. Titus-Ernstoff, A.E. Perry, et al., 
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Causes & Control, vol. 19, pp. 659-669, 2008.
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Human Carcinogens--Part D: Radiation. WHO International Agency for 
Research on Cancer Monograph Working Group,'' Lancet Oncology, vol. 
10, pp. 751-752, 2009.
    44. 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, pp. 562-566, 2005.
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Protection Practices Among Offspring of Women With Personal or 
Family History of Skin Cancer,'' Pediatrics, vol. 117, pp. e688-
e694, 2006.
    46. Goodhead, D.T., ``Initial Events in the Cellular Effects of 
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    48. Harrison, S.L., R. MacLennan, and P.G. Buettner, ``Sun 
Exposure and the Incidence of Melanocytic Nevi in Young Australian

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    50. Lever, L.R. and C.M. Lawrence, ``Nonmelanoma Skin Cancer 
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    51. Parr, C.L., A. Hjart[aring]ker, P. Laake, et al., ``Recall 
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    52. Ting, W., K. Schultz, N.N. Cac, et al., ``Tanning Bed 
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1994.

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, it is 
proposed that 21 CFR part 878 be 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 product.

    (a) Identification. An electronic product that includes one or more 
ultraviolet (UV) lamps and a fixture 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, tanning booths, and UV lamps (bulbs) sold 
separately.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Conduct performance testing that demonstrates the following:
    (i) Sunlamp products meet appropriate output performance 
specifications such as wavelengths, energy density, and lamp life; and
    (ii) Safety features, such as timers to limit UV exposure and 
alarms, function properly.
    (2) Demonstrate that sunlamp products are mechanically safe to 
prevent user injury.
    (3) Demonstrate software verification, validation, and hazard 
analysis.
    (4) Demonstrate that sunlamp products are biocompatible.
    (5) Demonstrate that sunlamp products are electrically safe and 
electromagnetically compatible in their intended use environment.
    (6) Labeling must bear all information required for the reasonable 
assurance of safe and effective use of the device.
    (i) The warning statement below must appear on all sunlamp product 
fixtures. 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 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.''

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

    Dated: May 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10982 Filed 5-6-13; 4:15 pm]
BILLING CODE 4160-01-P