[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
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2. Lam, R.W., A. Buchanan, J.A. Mador, et al., ``The Effects of
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3. Lee, T.M., C.C. Chan, J.G. Paterson, et al., ``Spectral
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6. National Institutes of Health, Office of Dietary Supplements,
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7. World Health Organization, ``Sunbeds, Tanning and UV
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10. Sivamani R.K., L.A. Crane, R.P. Dellavalle, et al., ``The
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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
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Screening and Genetic Testing,'' Dermatologic Therapy, vol. 19, pp.
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18. Reed, K.B., J.D. Brewer, C.M. Lohse, et al., ``Increasing
Incidence of Melanoma Among Young Adults: An Epidemiological Study
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19. Cust, A.E., B.K. Armstrong, C. Goumas, et al., ``Sunbed Use
During Adolescence and Early Adulthood Is Associated With Increased
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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
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23. ``IARC Working Group on Artificial Ultraviolet Light (UV)
and Skin Cancer: The Association of Use of Sunbeds With Cutaneous
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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
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42. Clough-Gorr, K.M., L. Titus-Ernstoff, A.E. Perry, et al.,
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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
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45. Geller, A.C., D.R. Brooks, G.A. Colditz, et al., ``Sun
Protection Practices Among Offspring of Women With Personal or
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e694, 2006.
46. Goodhead, D.T., ``Initial Events in the Cellular Effects of
Ionizing Radiations: Clustered Damage in DNA,'' International
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47. Han, J., G.A. Colditz, and D.J. Hunter, ``Risk Factors for
Skin Cancers: A Nested Case-Control Study Within the Nurses' Health
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1521, 2006.
48. Harrison, S.L., R. MacLennan, and P.G. Buettner, ``Sun
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49. Karagas, M.R., V.A. Stannard, L.A. Mott, et al., ``Use of
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Cancers. Journal of the National Cancer Institute, vol. 94, pp. 224-
226, 2002.
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