General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products, 31205-31214 [2014-12546]
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Rules and Regulations
Federal Register
Vol. 79, No. 105
Monday, June 2, 2014
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
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the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA–2013–N–0461]
General and Plastic Surgery Devices:
Reclassification of Ultraviolet Lamps
for Tanning, Henceforth To Be Known
as Sunlamp Products and Ultraviolet
Lamps Intended for Use in Sunlamp
Products
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK67QTVN1PROD with RULES
ACTION:
Final Order.
SUMMARY: The Food and Drug
Administration (FDA or the Agency) is
reclassifying ultraviolet (UV) lamps
intended to tan the skin from class I
(general controls) exempt from
premarket notification to class II
(special controls) and subject to
premarket notification, and renaming
them sunlamp products and UV lamps
intended for use in sunlamp products.
FDA is designating special controls that
are necessary to provide a reasonable
assurance of safety and effectiveness of
the device. FDA is reclassifying this
device on its own initiative based on
new information.
DATES: This order is effective September
2, 2014. See further discussion in
section V ‘‘Implementation Strategy’’ for
compliance dates.
FOR FURTHER INFORMATION CONTACT: Neil
R.P. Ogden, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm.1438, Silver Spring,
MD 20993–0002, 301–796–6397.
SUPPLEMENTARY INFORMATION:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) establishes a
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comprehensive system for the regulation
of medical devices intended for human
use. Section 513 of the FD&C Act (21
U.S.C. 360c) established three categories
(classes) of devices, reflecting the
regulatory controls needed to provide
reasonable assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval). One type of
general control provided by the FD&C
Act is a restriction on the sale,
distribution, or use of a device under
section 520(e) of the FD&C Act (21
U.S.C. 360j(e)). A restriction under
section 520(e) must be implemented
through rulemaking procedures, rather
than through the administrative order
procedures that apply to this
reclassification under section 513(e) of
the FD&C Act, as amended by the Food
and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112–
144).
Under section 513 of the FD&C Act,
devices that were in commercial
distribution before the enactment of the
1976 amendments, May 28, 1976
(generally referred to as preamendments
devices), are classified after FDA has: (1)
Received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
Applying these procedures, FDA has
classified most preamendments device
types.
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
postamendments devices), are
automatically classified under section
513(f)(1) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval unless, and
until, the device is classified or
reclassified into class I or II under
section 513(f)(2) or (f)(3) of the FD&C
Act or FDA issues an order finding the
device to be substantially equivalent, in
accordance with section 513(i) of the
FD&C Act, to a predicate device that
does not require premarket approval.
The Agency determines whether new
devices are substantially equivalent to
predicate devices by means of
premarket notification procedures in
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section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part
807).
On July 9, 2012, Congress enacted
FDASIA. Section 608(a) of FDASIA
amended the device reclassification
procedures under section 513(e) of the
FD&C Act, changing the process from
rulemaking to an administrative order.
Prior to the issuance of a final order
reclassifying a device, the following
must occur: (1) Publication of a
proposed order in the Federal Register;
(2) a meeting of a device classification
panel described in section 513(b) of the
FD&C Act; and (3) consideration of
comments to a public docket. The
proposed reclassification order must set
forth the proposed reclassification and a
substantive summary of the valid
scientific evidence concerning the
proposed reclassification, including the
public health benefits of the use of the
device, and the nature and incidence (if
known) of the risk of the device. (See
section 513(e)(1)(A)(i) of the FD&C Act.)
FDA issued a proposed reclassification
order for the devices that are the subject
of this final reclassification order on
May 9, 2013 (78 FR 27117).
Section 513(e) provides that FDA
may, by administrative order, reclassify
a device based upon ‘‘new information.’’
FDA can initiate a reclassification under
section 513(e) of the FD&C Act or an
interested person may petition FDA.
The term ‘‘new information,’’ as used in
section 513(e) of the FD&C Act, includes
information developed as a result of a
reevaluation of the data before the
Agency when the device was originally
classified, as well as information not
presented, not available, or not
developed at that time. (See, e.g.,
Holland-Rantos Co. v. United States
Department of Health, Education, and
Welfare, 587 F.2d 1173, 1174 n.1 (D.C.
Cir. 1978); Upjohn v. Finch, 422 F.2d
944 (6th Cir. 1970); Bell v. Goddard, 366
F.2d 177 (7th Cir. 1966).) Whether data
before the Agency are old or new data,
the ‘‘new information’’ to support
reclassification under section 513(e)
must be ‘‘valid scientific evidence,’’ as
defined in 21 CFR 860.7(c)(2). (See, e.g.,
Gen. Medical Co. v. FDA, 770 F.2d 214
(D.C. Cir. 1985); Contact Lens Mfrs.
Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.
1985), cert. denied, 474 U.S. 1062
(1986).)
FDA also regulates electronic
products, including sunlamp products
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and UV lamps intended for use in
sunlamp products, under chapter 5,
subchapter C of the FD&C Act (21 U.S.C.
360hh et seq.). Under these provisions,
FDA administers an electronic product
radiation control program to protect the
public health and safety. This authority
provides for developing, amending, and
administering radiation safety
performance standards for electronic
products. Sunlamp products and UV
lamps intended for use in sunlamp
products are subject to the regulations
for electronic product radiation control,
including 21 CFR parts 1000 through
1010 and § 1040.20 (21 CFR 1040.20).
The sunlamp products and UV lamps
intended for use in sunlamp products
performance standard in § 1040.20 was
originally published in the Federal
Register on November 9, 1979 (44 FR
65352). In the Federal Register of
September 6, 1985 (50 FR 36548), FDA
amended § 1040.20 and made it
applicable to all sunlamp products and
UV lamps intended for use in sunlamp
products manufactured on or after
September 8, 1986. FDA plans to
propose amendments to this
performance standard to reflect current
scientific knowledge related to sunlamp
product and UV lamp use, harmonize it
more closely with International
Electrotechnical Commission (IEC)
International Standard 60335–2–27, Ed.
5.0: 2009–12, and strengthen the
warning statement required by
§ 1040.20(d)(1)(i), in accordance with
the results of the study FDA conducted
under section 230 of the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85).
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II. Public Comments in Response to the
Proposed Order
FDA received over 2,500 comments in
response to the proposed order. Many of
these comments supported the proposal.
The comments that expressed concerns
raised many of the same issues as one
another. The comments can be
categorized in the following six areas:
(1) Terminology and definitions, (2)
procedural aspects of the classification,
(3) 510(k) notification, (4) special
controls, (5) underlying science, and (6)
miscellaneous comments. To make it
easier to identify comments and our
response to the comments, the word
‘‘Comment’’ appears before the
description of the comment, and the
word ‘‘Response’’ appears before our
response. We have also numbered each
comment to make it easier to identify a
particular comment. The number
assigned to each comment is purely for
organizational purposes and does not
signify the comment’s value or
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importance or the order in which it was
submitted.
A. Terminology and Definitions
(Comment 1) Why is the Agency using
such a broad interpretation of the term
‘‘sunlamp product’’ that includes
sunlamp products and UV lamps? The
Agency’s treatment of these products as
a single class of product is inconsistent
with the performance standard at
§ 1040.20, which identifies them as
distinct products. By treating them as a
single class of product, FDA is ignoring
differences in physical characteristics
between these products.
(Response 1) Prior to this
reclassification, UV lamps intended to
tan the skin and sunlamp products
incorporating UV lamps were regulated
together under the same classification
regulation, § 878.4635 (21 CFR
878.4635), as class I 510(k)-exempt
devices (subject to the limitations in 21
CFR 878.9, Limitations of exemptions
from section 510(k) of the Federal Food,
Drug, and Cosmetic Act). Manufacturers
appear to have understood that this
classification included both sunlamp
products and UV lamps, since they have
been listing both products under the
same product code in the Agency’s
Registration and Listing database.1
In the proposed reclassification order,
FDA proposed to rename the
classification regulation from
‘‘ultraviolet lamps for tanning’’ to
‘‘sunlamp products,’’ but after
considering comments submitted in
response to the proposed order, FDA
believes the proposed renaming would
not be sufficiently clear in its inclusion
of both sunlamp products and UV lamps
intended for use in sunlamp products.
Thus, in this final order, FDA has
renamed the regulation and revised the
definition of the product in
§ 878.4635(a) to more clearly indicate
that the regulation includes both
sunlamp products and UV lamps
intended for use in sunlamp products.
This language is consistent with the
terminology used in the performance
standard for these products in § 1040.20.
FDA acknowledges that there are
differences between sunlamp products
and UV lamps intended for use in
sunlamp products, and so has made
clear in this final order that certain
labeling requirements (see
§ 878.4635(b)(6)(i)) apply only to
sunlamp products whereas other
labeling requirements (see
§ 878.4635(b)(6)(ii)) apply to both
sunlamp products and and UV lamps
intended for use in sunlamp products.
1 See https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfrl/rl.cfm product code LEJ.
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Further, FDA is requiring that the
labeling special control at
§ 878.4635(b)(6)(i)(A) be placed in a
black box. For devices that have
significant risks that would make the
devices unsafe if used inappropriately,
FDA may require that the risks be
explained in warning statements placed
in a black box that is displayed
prominently in the labeling to ensure
awareness by the end user. In
conjunction with other regulatory
controls, awareness of these important
risks by the end user enables these
devices to be used safely. In this case,
a prominent black box warning that
identifies individuals who should not
use the device is necessary to allow
sunlamp products to be used safely.
B. Procedural Aspects of Classification
(Comment 2) The proposed order cites
several studies that were published
subsequent to the March 2010 General
and Plastic Surgery Advisory Panel (the
‘‘panel’’), underscoring the evolving
science in this space. By not convening
a new panel, is the Agency denying
stakeholders a fair opportunity to
address the methodology or other
concerns related to studies on which the
Agency is relying to take this action?
Further, by failing to convene a panel,
is the Agency failing to rely on up-todate medical research?
(Response 2) The 2010 panel
considered all relevant scientific issues
associated with sunlamp products and
UV lamps intended for use in sunlamp
products and recommended
upclassifying these devices. FDA is not
aware of any significant changes in
benefits or risks relating to sunlamp
products and UV lamps intended for use
in sunlamp products that have been
identified in the scientific literature
since the 2010 panel meeting. The
articles published since that meeting
offer further support for the panel’s
recommendation.
Of the 53 references cited in the
proposed order, only 4 are scientific
articles published after the 2010 panel.
Although these four articles were
published after the panel met to discuss
reclassification of sunlamp products
and UV lamps intended for use in
sunlamp products, the substance therein
is not ‘‘new’’ as it relates to issues
considered at the 2010 panel.
Specifically:
• Although Reference 1 (Reference 15
in the proposed order) was published
after the panel meeting, its conclusion—
that users with a history of melanoma
are at an increased risk for melanoma
reoccurrence—is also discussed in
research published in 2006 by
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Freedman, et al. (Ref. 2), which was
known at the time of the panel meeting.
• References 3 and 4 (References 18
and 19 in the proposed order) discuss
the effects of tanning in childhood and
early adult life, which were discussed
extensively by the panel. Some panel
members favored an age restriction for
indoor tanning (i.e., individuals under a
certain age would not be permitted to
use sunlamp products and UV lamps
intended for use in sunlamp products)
and thought that the cutoff age should
be 18.
• As discussed in the proposed order,
Reference 5 (Reference 28 in the
proposed order) showed that, despite
protective measures instituted in
commercial tanning facilities, 66
percent of female college-age users
reported skin erythema from indoor
tanning, and these users reported one
episode of sunburn out of every five
tanning sessions. These findings are
consistent with an earlier report (Ref. 6)
(Reference 29 in the proposed order)
published in 2009 that showed that 58
percent of adolescent indoor tanners
had experienced sunburns from
exposure to sunlamp products and UV
lamps intended for use in sunlamp
products.
Stakeholders had an opportunity to
raise concerns relating to the underlying
methodology of any studies FDA relied
on in the proposed order in their
comments on that proposed order. We
have addressed such comments in the
subsection ‘‘E. Underlying Science’’ in
this document.
(Comment 3) Using a panel meeting
that took place prior to the issuance of
the proposed reclassification order
violates the sequence of events for
issuing an administrative order to
change the classification of a device as
prescribed by section 513(e) of the
FD&C Act, as amended by FDASIA.
(Response 3) The process followed by
FDA in reclassifying these devices is in
accordance with the applicable statutory
provisions, which were recently
amended by FDASIA. Section 608 of
FDASIA amended section 513(e) of the
FD&C Act by changing the
reclassification process from rulemaking
to an administrative order process. The
amendments to section 513(e) of the
FD&C Act made by FDASIA, require, in
relevant part, that issuance of an
administrative order reclassifying a
device be preceded by a proposed order
and a meeting of a device classification
panel.
As amended, this section of the FD&C
Act does not prescribe when these two
events (the panel meeting and proposed
order) must occur in relation to each
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other. Therefore, this provision provides
the Agency with the flexibility to hold
a panel meeting either before or after the
issuance of a proposed reclassification
order. This approach is consistent with
the prior panel provision in section
513(e), which provided for FDA, at its
discretion, to secure a panel
recommendation prior to the
promulgation of a reclassification rule
and reflects longstanding practice.
Indeed, prior to FDASIA, when a panel
meeting was discretionary, FDA often
held a panel meeting prior to proposing
reclassification of a device, for example,
when the Agency determined that a
recommendation from the panel would
help inform whether proposing
reclassification for the device was
appropriate. FDA believes its
interpretation of section 513(e), as
amended by FDASIA, is reasonable and
allows the Agency to carry out the
reclassification of devices in the most
efficient and effective manner for the
Agency and all stakeholders.
FDA believes the panel’s deliberations
and recommendations from the meeting
held in March 2010 concerning
potential changes to the current
classification or regulatory controls for
sunlamp products and UV lamps
intended for use in sunlamp products
remain relevant and fully satisfy the
requirements in section 513(e) of the
FD&C Act. As explained in the proposed
reclassification order (Ref. 7), ‘‘No
significant changes in risks relating to
[sunlamp products and UV lamps
intended for use in sunlamp products]
have been identified in the scientific
literature since the 2010 panel meeting;
the same risks identified prior to the
2010 panel meeting continue to be
presented in literature.’’ Therefore,
convening another panel meeting on the
reclassification of sunlamp products
and UV lamps intended for use in
sunlamp products would be
unnecessarily duplicative and an
inefficient use of the time and resources
of all relevant parties.
(Comment 4) Comments were
submitted to the record in connection
with the 2010 panel meeting, including
a scientific critique of the scientific
papers on which FDA had relied. FDA’s
proposed order fails to address or
discuss the scientific submissions made
by the stakeholders. Did FDA take these
submissions into account, and, if so,
how were they addressed in the
proposed order?
(Response 4) Stakeholders submitted
139 comments to the docket for the 2010
panel meeting (Docket No. FDA–2009–
N–0606). Although FDA’s proposed
order does not directly discuss each
specific comment, the Agency did
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review and consider all received
comments in the development of its
proposed reclassification of sunlamp
products and ultraviolet lamps intended
for use in sunlamp products. The
proposed order includes the following
summary of the comments ‘‘The
majority of the input received via the
open public docket supported
strengthening FDA’s regulation of these
devices. Although many comments did
not expressly specify whether regulation
of sunlamps should be strengthened or
not, because most of these were related
to the experiences of people with
melanoma, FDA interpreted them to be
in support of stricter regulation of
sunlamps. Six comments of 139 total
comments took the position that FDA
should not change its current regulation
of indoor tanning devices. Overall, the
docket comments strongly paralleled the
opinions of the panel members (Ref. 7).’’
FDA considered not only the
comments received in the docket to the
2010 panel meeting, but also relevant
scientific literature, both in favor of and
against the use of sunlamp products. As
required by section 513(e) of the FD&C
Act, as amended by FDASIA, the
proposed order provided a substantive
summary of the valid scientific evidence
concerning the proposed reclassification
of the device, including the available
information on the benefits of use of
sunlamp products, as well as the risks
to health from use of these products.
The proposed order also called for
comments from any interested
stakeholders. The comment period on
the proposed order closed on August 7,
2013. All comments received were
considered by the Agency prior to
development of this final
reclassification order.
(Comment 5) The 2010 panel was not
representative of industry and certain
members of the panel had a conflict of
interest because they were partnered
with the American Academy of
Dermatology (AAD).
(Response 5) Advisory committees
provide FDA with independent advice
from outside experts. FDA’s advisory
committee program is governed by a
number of Federal laws and regulations
that set forth standards for convening
advisory committees and reviewing
potential conflicts of interest. FDA
remains committed to ensuring that its
advisory committee process is
conducted according to applicable
statutes and regulations and consistent
with relevant FDA guidance. These
laws, regulations, and guidance
documents are available on our Web
site, and provide ready access to the
statutory and regulatory framework that
FDA advisory committees operate
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within and describe the steps that FDA
has taken to enhance decisionmaking,
increase transparency, and strengthen
public confidence in our advisory
committee program.
FDA disagrees with the comment that
the composition of the 2010 panel was
flawed. A copy of the panel roster can
be found at the FDA’s Web site (Ref. 8).
The 2010 panel members were screened
for potential or actual conflicts of
interest in accordance with legal
requirements and consistent with FDA
guidance, and were cleared by the
Agency to participate at the meeting.2
As indicated on the panel roster, there
was a consumer representative, an
industry representative, and a patient
representative on the 16-person panel.
(Comment 6) Prior to the 2012
enactment of FDASIA, classifications
under section 513(e) of the FD&C Act
were governed by the Federal
rulemaking process requiring economic
analysis of any proposed regulations. At
any time after the Agency commenced
its reclassification efforts with respect to
sunlamp products and UV lamps
intended for use in sunlamp products in
2009, did the Agency undertake any
formal or informal economic analysis of
possible changes to the regulation of
this product?
(Response 6) The Federal rulemaking
process requires economic analysis of
proposed rules under Executive Order
12866. Section 608 of FDASIA amended
section 513(e) of the FD&C Act by
changing the reclassification process
from rulemaking to an administrative
order process. This order process is not
subject to Executive Order 12866.
Therefore, although the Agency
considered the impact on stakeholders
and the least burdensome method to
secure a reasonable assurance of safety
and effectiveness for sunlamp products
and UV lamps intended for use in
sunlamp products, the Agency has not
conducted an economic analysis for
reclassification of these devices.
FDA did consider the impact that this
reclassification may have on small
businesses and has decided to employ a
staged implementation plan to minimize
the burden on affected entities. Small
businesses play an important role in the
medical device industry and are
responsible for more than half of all
medical devices under development,
including sunlamp products and UV
lamps intended for use in sunlamp
products. Given this role, FDA
recognizes how critical it is that small
firms understand the regulatory
landscape in order to meet regulatory
2 See https://www.fda.gov/downloads/
RegulatoryInformation/Guidances/UCM125646.pdf.
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requirements for marketing. The
Division of Industry and Consumer
Education (DICE) in the Center for
Devices and Radiological Health (CDRH)
is dedicated to helping small businesses
successfully navigate the Agency’s
device approval and clearance
processes. In addition, small businesses
may qualify for substantially discounted
user fees—a 510(k) submission fee for a
small business in FY 2014 is $2,585,
which is half the standard 510(k)
submission fee.
(Comment 7) Because FDA has not
disclosed what the Agency will
ultimately require under amendments to
§ 1040.20, industry cannot adequately
comment on the proposed
reclassification order.
(Response 7) Manufacturers must
comply with the requirements set forth
in § 1040.20. If, in the future, § 1040.20
is updated, as FDA has announced its
intent to do, it will be done through its
own notice and comment rulemaking
process and stakeholders will be
provided the opportunity to comment
during that process.
(Comment 8) FDA should update the
requirements in § 1040.20 prior to the
implementation of this reclassification
because 510(k)s for these products that
are submitted prior to the performance
standard amendments would not
necessarily comply with the
performance standard and could require
manufacturers to have to submit
additional 510(k)s for their products.
(Response 8) With respect to
§ 1040.20, manufacturers must comply
with the performance standard in effect
at the time of the 510(k) submission. If
the performance standard is amended,
manufacturers would not need to
submit a new 510(k) unless there are
significant changes to the device that
trigger the need for a new 510(k)
submission under 21 CFR 807.81(a)(3)
(see FDA’s guidance ‘‘Deciding When to
Submit a 510(k) for a Change to an
Existing Device’’ (https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm080235.htm)).
C. 510(k) Notification
(Comment 9) Has FDA conducted any
analysis of the increased resources it
will need to enforce these new
regulations, including the demands
placed on the Agency to review 510(k)
premarket notifications?
(Response 9) A review of FDA’s
Establishment Registration and Device
Listing database, which identifies,
among other things, manufacturers that
are registered to market medical devices
and the devices that they currently
market, shows that there are
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approximately 25 firms registered as
sunlamp product manufacturers or
manufacturers of UV lamps intended for
use in sunlamps products. To continue
offering these devices for sale, a 510(k)
must be submitted by August 26, 2015,
(see further discussion in section V
‘‘Implementation Strategy’’). Thus, FDA
expects to receive approximately 25
510(k) submissions within this
timeframe (and potentially a few other
510(k) submissions for new sunlamp
products and UV lamps intended for use
in sunlamp products). FDA typically
receives and reviews approximately
4,000 510(k) submissions each year, so
the Agency does not expect the
reclassification of sunlamp products
and UV lamps intended for use in
sunlamp products to significantly affect
review times or resources.
As a part of the Medical Device User
Fee Amendments of 2012, or MDUFA
III, FDA committed to meeting certain
review times for 510(k) submissions.
FDA’s current review goal for 510(k)
submissions is to make a substantial
equivalence determination within 90
days of active FDA review. The latest
published review data from January 29,
2014, shows that FDA has met its
review goal for 100 percent of the 510(k)
submissions received in fiscal year
2014, to date. FDA expects to meet these
review goals for any 510(k) submission
for sunlamp products or UV lamps
intended for use in sunlamp products
(Ref. 9).
(Comment 10) Can the Agency clarify
by when it expects manufacturers to
submit a 510(k) notification for products
already being offered for sale, and
whether those products can continue to
be offered for sale after submission of
the 510(k) notification but prior to
Agency clearance?
(Response 10) Manufacturers of
sunlamp products or UV lamps
intended for use in sunlamp products
that are offered for sale prior to
September 2, 2014, must submit a
510(k) and comply with the labeling
special controls established in this final
order by August 26, 2015, which is 15
months from the date of publication of
this final order (see section V
‘‘Implementation Strategy’’) for any
device they wish to continue offering for
sale. Manufacturers can continue
offering these products for sale while
FDA reviews the 510(k) submissions.
However, if a 510(k) is not submitted or
the device is not in compliance with the
labeling special controls by this date, or
if FDA determines after review of the
510(k) that the device is not
substantially equivalent to a legally
marketed predicate device or the device
is not in compliance with the labeling
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or other special controls, the device,
including individual devices already in
use, would be adulterated and
misbranded under sections 501(f)(1)(B)
and 502(o) of the FD&C Act, and the
manufacturer would have to cease
offering the device for sale.
(Comment 11) The proposed order is
silent on the status of products that are
already on the market for which the
manufacturer is no longer in business or
for which it is not economically viable
for the manufacturer to incur the costs
associated with submitting a 510(k).
(Response 11) Individual sunlamp
products that have already been sold to
end users prior to September 2, 2014,
the model of which has been
discontinued or is otherwise no longer
marketed after this date, do not have to
have 510(k)s or comply with the nonlabeling special controls, but they must
comply with the labeling special
controls at § 878.4635(b)(6)(i)(A) by
August 26, 2015. If the manufacturer is
no longer in business, sunlamp product
owners would have to apply the
required labeling to sunlamp products
to keep these devices in compliance
with the labeling requirements.
(Comment 12) Is one 510(k) required
for a ‘‘sunlamp product,’’ which by
definition includes a fixture and UV
lamp, or are separate 510(k)s required
for the sunlamp product and UV lamp?
Similarly, if UV lamps are sold with a
sunlamp product and on their own, do
multiple 510(k)s need to be submitted?
(Response 12) In this final order, FDA
has revised the classification
identification to expressly include
‘‘sunlamp products’’ and ‘‘UV lamps
intended for use in sunlamp products’’
and has included revised definitions of
these devices, as discussed in response
to Comment 1. A 510(k) submission is
required for sunlamp products and for
UV lamps intended for use in sunlamp
products. If a UV lamp intended for use
in a sunlamp product is sold with a
sunlamp product or they are sold
separately from one another, then both
devices can be included in the same
510(k) submission. For more
information on this issue, please see
FDA Guidance, ‘‘Bundling Multiple
Devices or Multiple Indications in a
Single Submission,’’ available at https://
www.fda.gov/medicaldevices/
deviceregulationandguidance/
guidancedocuments/ucm089731.htm.
(Comment 13) If FDA is requiring that
UV lamp manufacturers submit 510(k)s
for their lamps, are lamp manufacturers
required to submit separate 510(k)s for
use of their lamps in each tanning bed
or booth? Or, can UV lamp
manufacturers that are required to
submit 510(k)s for their lamps do so
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without referencing use of the lamp
with a particular tanning bed or booth?
Is a replacement UV lamp manufacturer
required to submit a separate 510(k) for
use of each replacement lamp type in
each possible tanning bed or tanning
booth in which the replacement lamp
could conceivably be used?
(Response 13) Manufacturers of UV
lamps that submit a 510(k) do not need
to submit a separate 510(k) for use of
each replacement lamp type in each
possible tanning bed or tanning booth in
which the replacement lamp could
conceivably be used, but they should
specify in their 510(k) submission the
design characteristics of the sunlamp
product with which the lamp is
compatible.
(Comment 14) If FDA is requiring that
all UV lamp manufacturers, including
replacement lamp manufacturers,
submit 510(k)s, is a manufacturer of
replacement UV lamps required to
submit a separate 510(k) for each of its
lamp types? Will the Agency accept
510(k)s for lamp model families?
(Response 14) Instead of submitting
separate 510(k)s for different lamp
types, a manufacturer can submit a
‘‘bundled’’ 510(k) for related lamps. For
more information on this issue, please
see FDA Guidance, ‘‘Bundling Multiple
Devices or Multiple Indications in a
Single Submission,’’ available at https://
www.fda.gov/medicaldevices/
deviceregulationandguidance/
guidancedocuments/ucm089731.htm.
(Comment 15) Sunlamp product and
UV lamp manufacturers are aware of
cleared 510(k)s for ‘‘UV lamps for
tanning,’’ but at least some of these
510(k)s are over 20 years old. Over the
past 20 years, sunlamp products and UV
lamps have improved substantially with
regard to performance and safety.
Sunlamp product and UV lamp
manufacturers are uncertain how to
show substantial equivalence to one of
the 20-year-old sunlamp products or UV
lamps given these significant
improvements.
(Response 15) FDA will find a
contemporary sunlamp product or UV
lamp intended for use in a sunlamp
product to be substantially equivalent to
a predicate device if the contemporary
device: (1) Has the same intended use as
the predicate device and (2) has the
same technological characteristics as the
predicate device or has different
technological characteristics but is at
least as safe and effective as the
predicate device and does not raise new
questions of safety or effectiveness. If
the device has different technological
characteristics from the predicate
device, the 510(k) submission must
include a summary of how the
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31209
technological characteristics of the
device compare to a legally marketed
predicate device (21 CFR 807.92(a)(6)).
In addition to showing substantial
equivalence, manufacturers of new
sunlamp products will need to show
compliance with the special controls
required under this order.
(Comment 16) FDA should
‘‘grandfather’’ in all currently legally
marketed sunlamp products, such that
they would not be subject to the
requirements set forth in this order.
Moreover, these products should be
allowed to be used as predicate devices
as long as the manufacturers provide
adequate documentation that the
products meet all requirements
necessary for a 510(k) submission.
(Response 16) Manufacturers of
sunlamp products or UV lamps
intended for use in sunlamp products
that are offered for sale prior to
September 2, 2014, are required to
submit 510(k)s and must comply with
the labeling special controls by August
26, 2015, for any device they wish to
continue offering for sale. Any sunlamp
product or UV lamp intended for use in
a sunlamp product legally marketed on
or before September 2, 2014, including
both 510(k)-cleared and 510(k)-exempt
devices, can be used as a predicate
device in a 510(k). A 510(k) for such a
device must demonstrate that the device
was legally offered for sale on or before
September 2, 2014, and it must comply
with the special controls.
D. Special Controls
(Comment 17) Many of the proposed
special controls are either unrelated to
UV lamps intended to be used with
sunlamp products or are impossible for
UV lamp manufacturers to achieve
without involvement of a tanning bed or
tanning booth. For example, UV lamps
do not come into contact with indoor
tanners due to safety issues associated
with heat generation and possible lamp
breakage. Given this, how would UV
lamp manufacturers conduct
biocompatibility testing or comply with
some of the other special controls that
may apply only to sunlamp products?
(Response 17) If a certain non-labeling
special control does not, as a practical
matter, apply to a device due to the
device’s nature or design, manufacturers
may meet such special control by
explaining such practical inapplicability
in their 510(k) submission to FDA. For
example, biocompatibility testing would
not apply to a UV lamp that does not
contact the human body and the
software verification requirement would
not apply to a UV lamp that does not
employ software. As long as FDA finds
such justification acceptable, the
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manufacturer would not have to
conduct or submit any testing that
would otherwise be required by that
particular special control. FDA has
chosen this flexible approach, as
opposed to assigning certain special
controls to certain types of sunlamp
products and UV lamps intended for use
in sunlamp products, to account for
ever-changing technology in this area.
(Comment 18) FDA’s proposed
reclassification order would require that
certain warning labeling appear on
‘‘sunlamp product fixtures.’’ Given that
FDA specifies that the warning must
appear on ‘‘sunlamp product fixtures,’’
does this special control apply to UV
lamps?
(Response 18) Based on comments we
received, we have clarified the
applicability of the labeling
requirements in the final order. The
labeling in § 878.4635(b)(6)(i) pertains
only to sunlamp products while the
labeling in § 878.4635(b)(6)(ii) pertains
to sunlamp products and UV lamps
intended for use in sunlamp products.
This means that sunlamp products must
comply with the requirements in
§ 878.4635(b)(6)(i) and (b)(6)(ii), while
UV lamps intended for use in sunlamp
products must comply with
§ 878.4635(b)(6)(ii) and not with
§ 878.4635(b)(6)(i).
(Comment 19) A font height of 10
millimeters (mm) is too small for the
labeling prescribed in proposed
§ 878.4635(b)(6)(i).
(Response 19) FDA believes 10 mm is
sufficient height to attract attention and
warn prospective users that individuals
under age 18 should not use the device.
Ten mm is a minimum; labels are
permitted to display font greater than 10
mm.
E. Underlying Science
(Comment 20) The recent information
cited by FDA in the proposed
reclassification order is comprised
solely of recent reviews of information
that has been available for several years,
and this information does not compel a
change to the current classification or
performance standards.
(Response 20) The articles referenced
in the proposed order qualify as ‘‘new
information’’ under section 513(e) of the
FD&C Act. The term ‘‘new information,’’
as used in section 513(e) of the FD&C
Act, includes information developed as
a result of a reevaluation of the data
before the Agency when the device was
originally classified, as well as
information not presented, not
available, or not developed at that time.
(See, e.g., Holland-Rantos Co. v. United
States Department of Health, Education,
and Welfare, 587 F.2d 1173, 1174 n.1
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(D.C. Cir. 1978); Upjohn v. Finch, 422
F.2d 944 (6th Cir. 1970); Bell v.
Goddard, 366 F.2d 177 (7th Cir. 1966).).
The sources cited in the proposed
reclassification order are all
encompassed by this definition and
reveal, among other things, that UV
radiation is a significant contributing
factor in developing skin cancer, that
the number of females exposed to
indoor UV radiation who are diagnosed
with skin cancer is increasing, and that
individuals under 18 who are exposed
to UV radiation are at an increased risk
of developing skin cancer. As stated in
the proposed order, the cumulative
effects of UV radiation exposure have
been linked to higher incidence of skin
cancer (Ref. 10). Moreover, individuals
under 18 are particularly vulnerable to
the damaging effect of UV radiation.
According to a 2008 article
recommending an age restriction to
prevent sunlamp product use in
children and teenagers, a number of
biological factors are identified as
potentially causing the increase in the
risk of developing melanoma from
exposure to sunlamps during those
years (Ref. 11). These findings have
compelled a change in how FDA
regulates these devices.
(Comment 21) Sunlamp products can
stimulate the body to produce vitamin
D. In addition to bone problems and
increased cancer risk, vitamin D
deficiency has been linked to a
heightened risk of Type 1 diabetes,
multiple sclerosis and other
autoimmune diseases, infectious
diseases such as influenza and
tuberculosis, and high blood pressure.
For these reasons, additional regulation
of sunlamp products is not appropriate.
(Response 21) FDA agrees that
vitamin D is critical for the body’s
health. In the proposed order, FDA
acknowledged that UV radiation
stimulates the body’s production of
vitamin D, however, there are safer
alternatives to obtain vitamin D other
than the use of sunlamp products and
UV lamps intended to be used in
sunlamp products, for example, through
an individual’s diet (Ref. 12). As stated
previously, FDA believes that additional
regulation is necessary to provide a
reasonable assurance of safety and
effectiveness of these devices.
(Comment 22) FDA should not rely on
the International Agency for Research
on Cancer’s (IARC) study (Ref. 13) to
support this reclassification because
that study included outdoor sun
exposure and dermatology exposure,
which confounded the data and
exaggerated the effects of UV radiation.
(Response 22) As with most indoor
tanning risk studies, it can be difficult
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to discern for each subject the relative
amounts of indoor and outdoor UV
exposure. However, previous use of a
sunlamp product and frequency of use
can be assessed to determine relative
risk of indoor tanning exposure. All of
the studies analyzed in the IARC study
focused on indoor tanning and
melanoma as well as other skin cancers
such as basal cell carcinoma and
squamous cell carcinoma. FDA believes
the IARC report’s conclusions are
applicable to indoor tanning.
(Comment 23) Even though women’s
use of indoor tanning devices has
increased in recent years, SEER cancer
incidence data shows that the incidence
of melanoma has decreased from 5.0 in
1975–1982 to 2.3 in 1981–2010 in
females (Ref. 14). This finding
undermines the argument that indoor
tanning causes melanoma.
(Response 23) The SEER incidence
data referenced in the comment is
incorrect. In the SEER data, an increase
in the incidence of melanoma in females
has been noted since 1975 and has not
abated. The age adjusted rates of
melanoma for females per 100,000 are as
follows (Ref. 15):
TABLE 1
SEER
Melanoma
incidence
per 100,000
females
Year
1975
1980
1985
1990
1995
2000
2005
2010
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
7.44
9.63
11.16
11.84
13.81
15.50
18.41
19.30
The increase in melanoma incidence
among white females is even greater
(Ref. 15):
TABLE 2
Year
1975
1980
1985
1990
1995
2000
2005
2010
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
SEER
melanoma
incidence
per 100,000
white
females
8.21
11.12
12.70
13.93
16.47
19.08
23.14
24.23
(Comment 24) The IARC report shows
only a 1⁄10 of 1 percent increase in risk
of melanoma. The IARC report clearly
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states that epidemiologic studies do not
support a consistent relationship
between tanning and cancer.
(Response 24) FDA is unaware of the
source of the 1⁄10 of 1 percent value
referenced by the commenter. Rather,
the IARC report identified a causal
relationship between indoor tanning
and melanoma risk based on evidence
pertaining to the strength, consistency,
dose-response and temporal sequence of
the association of the use of sunlamp
products with melanoma risk, and of the
coherence and biologic plausibility of
the association (Ref. 13). Additionally,
the study found that first exposure to
sunlamp products before age 35
increased the risk of melanoma by 75
percent compared to individuals that
never used sunlamp products.
(Comment 25) The cause of melanoma
is unknown, although most scientists
believe the primary cause is genetic in
nature. The personal risk factors for
melanoma include red hair, extremely
pale skin that will not tan, presence of
moles and freckles on the body, and a
family history of melanoma.
Upclassifying these devices, and
limiting exposure to UV radiation, is not
necessary for those without a genetic
predisposition to melanoma.
(Response 25) Although personal risk
factors can also contribute to the risk for
melanoma, there have been multiple
studies which have found that sunlamp
product use increases the risk of
melanoma. Meta analyses by Gallagher
et al. (Ref. 16), IARC (Ref. 13), and
Boniol et al. (Ref. 17) have all found a
link between sunlamp product use and
melanoma.
(Comment 26) The literature is replete
with conflicting information, including
science suggesting that moderate, nonburning UV exposure reduces the risk of
melanoma and that sunburn is the
relevant exposure circumstance to be
avoided, whether the UV comes from
the sun or from a tanning bed, and
whether the person is older or younger
than 18. Sunburn prevention as the
correct approach is supported by
research showing that biologically,
sunburn affects the skin differently
when compared to non-burning UV
exposure. Sunburning should be
avoided, but moderate exposure by
individuals—regardless of the user’s
age—is not risky.
(Response 26) As stated in FDA’s
proposed order to reclassify these
devices, there is no evidence that
moderate non-burning UV exposure or
attaining a ‘‘base tan’’ provides any
protection against premature aging of
the skin or reduces the risk of skin
cancer (Ref. 7). The Agency concurs
with the comment that there are other
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risk factors for melanoma besides
sunbed use.
(Comment 27) Dr. David G. Hoel, 1 of
the 20 scientists that were called upon
by the IARC in 2009 to reassess the
carcinogenicity of all forms of radiation,
has written a report stating that the 2006
IARC conclusion that there is a 75
percent increase in melanoma risk when
tanning starts before age 35 is invalid.
Dr. Hoel is preparing an article for
publication on the subjects of
melanoma, UV radiation, and the IARC
report. The purpose of this article is to
correct the many misconceptions about
the science regarding UV radiation and
melanoma that have been promoted by
the AAD and other anti-tanning
advocates. Dr. Hoel argues that the
significant differences between
regulatory standards in the United
States and Europe with regard to use of
sunlamp products make the
predominantly European data in the
IARC report an inappropriate basis for
the FDA’s decision to change the
controls applicable to sunlamp products
in the United States.
(Response 27) The paper alluded to
has not been published or undergone
peer review. Studies subsequent to the
IARC study have corroborated that
study’s findings that there is a
correlation between melanoma and
sunlamp product use. For example, a
meta-analysis employing data from
numerous studies found an increased
risk of melanoma with sunlamp product
use (Ref. 17). Furthermore, this study
noted that the magnitude of the
increased risk was greater when
sunlamp product use began earlier in
´
life. In addition, Dore and Chignol
observed that two studies in Minnesota
and Australia found an increased risk of
melanoma with indoor tanning (Ref. 18).
They also observed a very large study of
Norwegian and Swedish women that
found an increased risk of melanoma
with indoor tanning.
(Comment 28) After further analysis
of the IARC report, Dr. Mia Papas and
Dr. Anne Chappelle published a peerreviewed report (Ref. 19) criticizing the
IARC report for not differentiating
among Medical Phototherapy
Equipment, Unsupervised Home
Equipment, and Commercial Tanning
Salon Equipment. Their article indicates
that there is no association between
sunlamp product use and melanoma if
you remove home use and medical use
of sunlamp products from the analysis.
Therefore, the report being used to
support the reclassification is flawed.
(Response 28) This literature (Ref. 19)
has not been published in a peerreviewed journal, despite the
commenter’s assertion to the contrary.
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In the peer-reviewed journal ‘‘Cancer
Epidemiology, Biomarkers &
Prevention,’’ Gallagher et al. (Ref. 16)
noted that the results from studies
subsequent to the IARC report, taken
together, do not differ in character from
those seen in the earlier studies. During
earlier studies, home use of sunlamp
products was greater than it is now.
During later studies, the proportion of
the sunlamp product use at indoor
tanning facilities increased greatly, but
according to Gallagher et al. (Ref. 16),
melanoma incidence did not markedly
differ, supporting the conclusion that
the risk from use of sunlamp products
at tanning facilities does not differ
markedly from the risks of home use of
such devices.
(Comment 29) An article written by
William Grant (Ref. 20) indicated that
the 50 subjects in the IARC report were
primarily skin type 1. Skin type 1
individuals have a natural increased
risk to skin cancer and because tanning
facilities do not tan skin type 1’s, this
skewed the data in the IARC report.
(Response 29) The Grant critique (Ref.
20) points out that fair skinned
individuals are more likely than other
individuals to develop skin cancer due
to UV exposure. However, UV radiation
exposure from indoor tanning use
increases the risk of skin cancer
regardless of whether individuals have
high or low pigmentation (Ref. 21). For
this reason, FDA has not changed its
position regarding the link between
sunlamp product use and skin cancer. It
is also important to note that a
significant portion of the U.S.
population is skin type 1 and may use
sunlamp products (Ref. 22).
F. Miscellaneous
(Comment 30) Unless tanning beds for
home use are banned, this
reclassification does not make sense.
(Response 30) The commenter did not
provide a justification for this
conclusion, so we are not completely
clear as to the basis for this comment.
However, we emphasize that the new
510(k) requirements and special
controls (including labeling) set forth in
this final order apply to all sunlamp
products and UV lamps intended to be
used in sunlamp products, including
ones sold to individuals for home use.
FDA believes that the regulatory
controls set forth in this order are
necessary to provide a reasonable
assurance of safety and effectiveness for
these devices.
(Comment 31) Regulated tanning
facilities are a safer alternative than
home tanning where there are no
informed workers. Tanning facility
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owners are trained and educated to
protect clients who want to tan.
(Response 31) This final order does
not distinguish between devices sold for
use at home and devices sold to tanning
facilities; the regulatory controls set
forth in this order apply to both.
(Comment 32) People who have
prescriptions for dermatological
disorders will be burdened by this
reclassification.
(Response 32) Devices prescribed for
individuals with dermatological
disorders have been and will continue
to be regulated differently from devices
regulated under § 878.4635. UV lamps
for dermatological disorders have long
been class II medical devices regulated
under 21 CFR 878.4630 and are
unaffected by this reclassification.
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III. The Final Order
Under section 513(e) of the FD&C Act,
FDA is adopting its findings as
published in the preamble to the
proposed order. FDA is issuing this final
order to reclassify UV lamps used to tan
the skin from class I (general controls)
exempt from premarket notification to
class II (special controls) and subject to
premarket notification and rename them
sunlamp products and UV lamps
intended for use in sunlamp products.
IV. Premarket Notification
Class II devices are subject to the
510(k) premarket notification
requirement unless exempted under
section 510(m) of the FD&C Act. Under
this reclassification, the Agency is not
exempting these devices from premarket
notification (510(k)) submission
requirements as provided for under
section 510(m) of the FD&C Act. The
premarket notification requirement
allows the Agency to review the
technological characteristics,
performance, intended use(s), and
labeling of medical devices to ensure
the devices are substantially equivalent
to legally marketed predicate devices
before they enter the market. Substantial
equivalence requires that a new device
must have: (1) The same intended use
as legally marketed predicates and (2)
either the same technological
characteristics as a legally marketed
predicate, or if there are significant
differences, the differences must not
raise new questions of safety and
effectiveness and the performance data
must demonstrate that the new device is
at least as safe and effective as the
legally marketed predicate device. (See
section 513(i) of the FD&C Act.) This
assures that new devices that differ
significantly in terms of safety and
effectiveness from predicate devices
already legally on the market will be
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subject to the more rigorous premarket
approval requirement.
FDA cleared several 510(k)s for
sunlamp products prior to exempting
the devices from premarket notification
submission.3 At least one 510(k) for a
sunlamp product has been cleared since
then under product code LEJ. These
cleared sunlamp products, as well as
any 510(k)-exempt sunlamp product or
UV lamp intended for use in a sunlamp
product legally offered for sale on or
before September 2, 2014, can serve as
predicates for substantial equivalence
purposes.
V. Implementation Strategy
Based on comments on the proposed
order regarding our implementation
strategy, we are clarifying the
compliance dates for the various
requirements set forth in this final
order. For additional information on
this issue, see the DATES heading of this
final order.
• Models of sunlamp products and
UV lamps intended for use in sunlamp
products that have not been offered for
sale prior to September 2, 2014, or have
been offered for sale but are required to
submit a new 510(k) under
§ 807.81(a)(3) because the device is
about to be significantly changed or
modified: 4 Manufacturers must obtain
510(k) clearance before marketing the
new or changed device.
• Models of sunlamp products and
UV lamps intended for use in sunlamp
products that have been offered for sale
prior to September 2, 2014, and
continue to be offered for sale after this
date: Manufacturers must submit a
510(k) and comply with labeling special
controls by August 26, 2015, for any
device they wish to continue offering for
sale. If a 510(k) is not submitted by this
date or the device is not in compliance
with the labeling special controls or if
FDA determines after review of the
510(k) that either the device is not
substantially equivalent to a legally
marketed predicate or the device is not
in compliance with the labeling or other
special controls, the device model
would be adulterated and misbranded,
and offering the device for sale would
have to cease.
• Individual sunlamp products that
have been shipped to operators or users
such as tanning facilities and individual
consumers prior to September 2, 2014,
3 See
59 FR 63005 (December 7, 1994).
FDA’s guidance, ‘‘Deciding When to Submit
a 510(k) for a Change to an Existing Device,’’
(available at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/Guidance
Documents/ucm080235.htm), for additional
guidance on whether a device change or
modification requires a 510(k) submission.
4 See
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the model of which has been
discontinued or is otherwise no longer
offered for sale: These devices must
comply with the labeling special
controls at § 878.4635(b)(6)(i)(A) by
August 26, 2015. If the manufacturer is
no longer in business, sunlamp product
owners would have to apply the
required labeling to keep these devices
in compliance with the labeling
requirements.
VI. Environmental Impact
The Agency has determined under 21
CFR 25.34(b) that this reclassification
action is of a type that does not
individually or cumulatively have a
significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VII. Paperwork Reduction Act of 1995
This final order refers to currently
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (the PRA) (44
U.S.C. 3501–3520). The collections of
information in part 807, subpart E, have
been approved under OMB control
number 0910–0120 and the collections
of information under 21 CFR part 801
have been approved under OMB control
number 0910–0485.
In addition, FDA concludes that the
labeling statements in § 878.4635(b)(6)(i)
(A) and (b)(6)(ii)(A) through (b)(6)(ii)(D)
do not constitute a ’’collection of
information’’ under the PRA. Rather, the
labeling statements are ’’public
disclosure of information originally
supplied by the Federal Government to
the recipient for the purpose of
disclosure to the public.’’ (5 CFR 1320.3
(c)(2)).
VIII. Codification of Orders
Prior to the amendments by FDASIA,
section 513(e) provided for FDA to issue
regulations to reclassify devices.
Although section 513(e) as amended
requires FDA to issue final orders rather
than regulations, FDASIA also provides
for FDA to revoke previously issued
regulations by order. FDA will continue
to codify classifications and
reclassifications in the Code of Federal
Regulations (CFR). Changes resulting
from final orders will appear in the CFR
as changes to codified classification
determinations or as newly codified
orders. Therefore, under section
513(e)(1)(A)(i) of the FD&C Act, as
amended by FDASIA, in this final order,
we are revoking the requirements in
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§ 878.4635 related to the classification
of UV lamps for tanning as class I
devices and codifying the
reclassification of sunlamp products
and UV lamps intended for use in
sunlamp products into class II.
emcdonald on DSK67QTVN1PROD with RULES
IX. References
FDA has placed the following
references on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Interested persons may see them
between 9 a.m. and 4 p.m., Monday
through Friday, and online at https://
www.regulations.gov. (FDA has verified
all the Web site addresses in this
reference section, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Salama, A.K., N. de Rosa, R.P. Scheri, et
al., ‘‘Hazard-Rate Analysis and Patterns of
Recurrence in Early Stage Melanoma:
Moving Towards a Rationally Designed
Surveillance Strategy,’’ PLoS One, vol. 8,
pp. e576–e665, 2013.
2. Freedman, D.B., B.A. Miller, and M.A.
Tucker, ‘‘New Malignancies Following
Melanoma of Skin, Eye Melanoma, and
Nonmelanoma Eye Cancer,’’ New
Malignancies Among Cancer Survivors:
SEER Cancer Registries, 1973–2000, pp.
339–362, 2006.
3. Reed, K.B., J.D. Brewer, C.M. Lohse, et al.,
‘‘Increasing Incidence of Melanoma Among
Young Adults: An Epidemiological Study
in Olmsted County, Minnesota,’’ Mayo
Clinic Proceedings, vol. 87, pp. 328–334,
2012.
4. Cust, A.E., B.K. Armstrong, C. Goumas, et
al., ‘‘Sunbed Use During Adolescence and
Early Adulthood Is Associated With
Increased Risk of Early-Onset Melanoma,’’
International Journal of Cancer, vol. 128,
pp. 2425–2435, 2011.
5. Stapleton, J.L., J. Hillhouse, R. Turrisi, et
al., ‘‘Erythema and Ultraviolet Tanning:
Findings From a Diary Study,’’
Translational Behavioral Medicine, vol. 3,
pp. 10–16, 2013.
6. Cokkinides, V., M. Weinstock, D. Lazovich,
et al., ‘‘Indoor Tanning Use Among
Adolescents in the United States, 1998–
2004,’’ Cancer, vol. 115, pp. 190–198,
2009.
7. 78 FR 27117, May 9, 2013.
8. https://www.fda.gov/downloads/Advisory
Committees/CommitteesMeetingMaterials/
MedicalDevices/MedicalDevicesAdvisory
Committee/GeneralandPlasticSurgery
DevicesPanel/UCM205686.pdf.
9. https://www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
Overview/MedicalDeviceUserFeeand
ModernizationActMDUFMA/UCM383896.
pdf.
10. Sivamani, R.K., L.A. Crane, R.P.
Dellavalle, et al.,’’ The Benefits and Risks
of Ultraviolet Tanning and Its Alternatives:
The Role of Prudent Sun Exposure,’’
Dermatologic Clinics, vol. 27, pp. 149–154,
2009.
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15:44 May 30, 2014
Jkt 232001
11. Autier, P. and P. Boyle, ‘‘Artificial
Ultraviolet Sources and Skin Cancers:
Rationale for Restricting Access to Sunbed
Use Before 18 Years of Age,’’ Nature
Clinical Practice Oncology, vol. 5(4), pp.
178–179, 2008.
12. National Institutes of Health, Office of
Dietary Supplements, ‘‘Dietary Supplement
Fact Sheet: Vitamin D’’ (https://ods.od
.nih.gov/factsheets/VitaminD-Health
Professional).
13. ‘‘IARC Working Group on Artificial
Ultraviolet Light (UV) and Skin Cancer:
The Association of Use of Sunbeds With
Cutaneous Malignant Melanoma and Other
Skin Cancers: A Systematic Review,’’
International Journal of Cancer, vol. 120,
pp. 1116–1122, 2006.
14. SEER Stat Fact Sheets: Melanoma of the
Skin, https://seer.cancer.gov/statfacts/html/
melan.html#incidence-mortality.
15. SEER Cancer Statistics Review 1975–
2010, https://seer.cancer.gov/csr/1975_
2010/browse_csr.php?sectionSEL=16&page
SEL=sect_16_table.05.html.
16. Gallagher, R.P., J.J. Spinelli, and T.K. Lee,
‘‘Tanning Beds, Sunlamps, and Risk of
Cutaneous Malignant Melanoma,’’ Cancer
Epidemiology, Biomarkers & Prevention,
vol. 14(3), pp. 562–566, 2005.
17. Boniol, M., P. Autier, P. Boyle, et al.,
‘‘Cutaneous Melanoma Attributable to
Sunbed Use: Systematic Review and MetaAnalysis,’’ British Medical Journal, vol.
345, p. e4757 July 24, 2012.
´
18. Dore, J. and M.C. Chignol, ‘‘Tanning
Salons and Skin Cancer,’’ Photochemical &
Photobiological Sciences, vol. 11(1), pp.
30–37, 2012.
19. https://www.google.com/url?sa=t&rct=j
&q=&esrc=s&source=web&cd=1&
ved=0CCkQFjAA&url=http%3A%2F%2F
tancanada.org%2Fwp-content%2F
uploads%2F2013%2F05%2Fsuntan_
poster_4-final-Montreal.pdf&ei=u8B8U7ii
FdbesATr7oGoCA&usg=AFQjCNFNm
LHAAiGcthuPeFfKj94zhexEaw&sig2=IZOwr4jPtD8ql5fvhV7Vg&bvm=bv.67229260,
d.cWc&cad=rja.
20. Grant, W.B., ‘‘Critique of the International
Agency for Research on Cancer’s MetaAnalyses of the Association of Sunbed Use
With Risk of Cutaneous Malignant
Melanoma,’’ Dermatoendocrinology, vol.
1(6), pp. 294–299, 2009.
21. Zhang, M., A.A. Qureshi, A.C. Geller, et
al., ‘‘Use of Tanning Beds and Incidence of
Skin Cancer,’’ Journal of Clinical Oncology,
vol. 30, pp. 1588–1593, 2012.
22. Mayer, J.A., S.I. Woodruff, D.J. Slymen,
et al., ‘‘Adolescents’ Use of Indoor
Tanning: A Large-Scale Evaluation of
Psychosocial, Environmental, and PolicyLevel Correlates,’’ American Journal of
Public Health, vol. 101(5), pp. 930–938,
2011.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 878 is
amended as follows:
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
31213
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
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.
2. Section 878.4635 is revised to read
as follows:
■
§ 878.4635 Sunlamp products and
ultraviolet lamps intended for use in
sunlamp products.
(a) Identification. A sunlamp product
is any device designed to incorporate
one or more ultraviolet (UV) lamps
intended for irradiation of any part of
the living human body, by UV radiation
with wavelengths in air between 200
and 400 nanometers, to induce skin
tanning. This definition includes
tanning beds and tanning booths. A UV
lamp intended for use in sunlamp
products is any lamp that produces UV
radiation in the wavelength interval of
200 to 400 nanometers in air.
(b) Classification. Class II (special
controls). The special controls for
sunlamp products and UV lamps
intended for use in sunlamp products
are:
(1) Conduct performance testing that
demonstrates the following:
(i) Device meets appropriate output
performance specifications such as
wavelengths, energy density, and lamp
life; and
(ii) Device’s safety features, such as
timers to limit UV exposure and alarms,
function properly.
(2) Demonstrate that device is
mechanically safe to prevent user
injury.
(3) Demonstrate software verification,
validation, and hazard analysis.
(4) Demonstrate that device is
biocompatible.
(5) Demonstrate that device is
electrically safe and electromagnetically
compatible in its intended use
environment.
(6) Labeling—(i) Sunlamp products.
(A) The warning statement below must
appear on all sunlamp products and
must be placed in a black box. This
statement must be permanently affixed
or inscribed on the product when fully
assembled for use so as to be legible and
readily accessible to view by the person
who will be exposed to UV radiation
immediately before the use of the
product. It shall be of sufficient
durability to remain legible throughout
the expected lifetime of the product. It
shall appear on a part or panel
displayed prominently under normal
conditions of use so that it is readily
accessible to view whether the tanning
bed canopy (or tanning booth door) is
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Federal Register / Vol. 79, No. 105 / Monday, June 2, 2014 / Rules and Regulations
open or closed when the person who
will be exposed approaches the
equipment and the text shall be at least
10 millimeters (height). Labeling on the
device must include the following
statement:
Attention: This sunlamp product should not
be used on persons under the age of 18
years.
(B) Manufacturers shall provide
validated instructions on cleaning and
disinfection of sunlamp products
between uses in the user instructions.
(ii) Sunlamp products and UV lamps
intended for use in sunlamp products.
Manufacturers of sunlamp products and
UV lamps intended for use in sunlamp
products shall provide or cause to be
provided in the user instructions, as
well as all consumer-directed catalogs,
specification sheets, descriptive
brochures, and Web pages in which
sunlamp products or UV lamps
intended for use in sunlamp products
are offered for sale, the following
contraindication and warning
statements:
(A) ‘‘Contraindication: This product is
contraindicated for use on persons
under the age of 18 years.’’
(B) ‘‘Contraindication: This product
must not be used if skin lesions or open
wounds are present.’’
(C) ‘‘Warning: This product should
not be used on individuals who have
had skin cancer or have a family history
of skin cancer.’’
(D) ‘‘Warning: Persons repeatedly
exposed to UV radiation should be
regularly evaluated for skin cancer.’’
(c) Performance standard. Sunlamp
products and UV lamps intended for use
in sunlamp products are subject to the
electronic product performance
standard at § 1040.20 of this chapter.
Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12546 Filed 5–29–14; 11:15 am]
emcdonald on DSK67QTVN1PROD with RULES
BILLING CODE 4160–01–P
DEPARTMENT OF TRANSPORTATION
Federal Transit Administration
49 CFR Part 613
Federal Highway Administration
23 CFR Part 450
[Docket No. FTA–2013–0029]
Policy Guidance on Metropolitan
Planning Organization (MPO)
Representation
AGENCIES: Federal Transit
Administration (FTA) and Federal
Highway Administration (FHWA), DOT.
ACTION: Policy guidance.
SUMMARY: The FTA and FHWA are
jointly issuing this guidance on
implementation of provisions of the
Moving Ahead for Progress in the 21st
Century Act (MAP–21), that require
representation by providers of public
transportation in each metropolitan
planning organization (MPO) that serves
a transportation management area
(TMA) no later than October 1, 2014.
The purpose of this guidance is to assist
MPOs and providers of public
transportation in complying with this
new requirement.
DATES: Effective June 2, 2014.
FOR FURTHER INFORMATION CONTACT:
Dwayne Weeks, FTA Office of Planning
and Environment, telephone (202) 366–
4033 or Dwayne.Weeks@dot.gov; or
Harlan Miller, FHWA Office of
Planning, telephone (202) 366–0847 or
Harlan.Miller@dot.gov.
SUPPLEMENTARY INFORMATION:
Introduction
The FTA and FHWA are jointly
issuing this policy guidance on the
implementation of 23 U.S.C.
134(d)(2)(B) and 49 U.S.C. 5303(d)(2)(B),
as amended by sections 1201 and 20005
of MAP–21, Public Law 112–141, which
require representation by providers of
public transportation in each MPO that
serves an area designated as a TMA by
October 1, 2014.1 A TMA is defined as
an urbanized area with a population of
over 200,000 individuals as determined
by the 2010 census, or an area with a
population of fewer than 200,000
1 ‘‘Not later than 2 years after the date of
enactment of the Federal Public Transportation Act
of 2012, each metropolitan planning organization
that serves an area designated as a transportation
management area shall consist of . . . officials of
public agencies that administer or operate major
modes of transportation in the metropolitan area,
including representation by providers of public
transportation.’’ 49 U.S.C. 5303(d)(2)(B). See also 23
U.S.C. 134(d)(2)(B).
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individuals that is designated as a TMA
by the request of the Governor and the
MPO designated for the area.2 As of the
date of this guidance, of the
approximately 420 MPOs throughout
the Nation, approximately 210 MPOs
serve an area designated as a TMA. The
FTA and FHWA will issue a joint notice
of proposed rulemaking to amend 23
CFR part 450 and 49 CFR part 613 to
make these planning regulations
consistent with these and other current
statutory requirements. Once FTA and
FHWA issue a final rule amending the
planning regulations, MPOs must
comply with the requirements in those
regulations.
To increase the accountability and
transparency of the Federal-aid highway
and Federal transit programs and to
improve project decisionmaking
through performance-based planning
and programming, MAP–21 establishes
a performance management framework.
The MAP–21 requires FHWA to
establish, through a separate
rulemaking, performance measures and
standards to be used by States to assess
the condition of the pavements and
bridges, serious injuries and fatalities,
performance of the Interstate System
and National Highway System, traffic
congestion, on-road mobile source
emissions, and freight movement on the
Interstate System.3 The MAP–21 also
requires FTA to establish, through
separate rulemakings, state of good
repair and safety performance measures,
and requires each provider of public
transportation to establish performance
targets in relation to these performance
measures.4
To establish performance targets that
address these performance measures,
States and MPOs must coordinate their
targets with each other to ensure
consistency, to the maximum extent
practicable.5 For transit-related
performance targets, States and MPOs
must coordinate their targets relating to
safety and state of good repair with
providers of public transportation to
ensure consistency with other
performance-based provisions
applicable to providers of public
transportation, to the maximum extent
practicable.6 An MPO must describe in
its metropolitan transportation plans the
performance measures and targets used
to assess the performance of its
transportation system.7 Statewide and
metropolitan transportation
2 23
U.S.C. 134(k)(1); 49 U.S.C. 5303(k)(1).
U.S.C. 150(c).
4 49 U.S.C. 5326(b), (c), 5329(b), (d).
5 23 U.S.C. 134(h)(2); 49 U.S.C. 5303(h)(2).
6 23 U.S.C. 134(h)(2); 49 U.S.C. 5303(h)(2).
7 23 U.S.C. 134(i)(2)(B); 49 U.S.C. 5303(i)(2)(B).
3 23
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]]>Agencies
[Federal Register Volume 79, Number 105 (Monday, June 2, 2014)]
[Rules and Regulations]
[Pages 31205-31214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12546]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 79, No. 105 / Monday, June 2, 2014 / Rules
and Regulations
[[Page 31205]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2013-N-0461]
General and Plastic Surgery Devices: Reclassification of
Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp
Products and Ultraviolet Lamps Intended for Use in Sunlamp Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Final Order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reclassifying ultraviolet (UV) lamps intended to tan the skin from
class I (general controls) exempt from premarket notification to class
II (special controls) and subject to premarket notification, and
renaming them sunlamp products and UV lamps intended for use in sunlamp
products. FDA is designating special controls that are necessary to
provide a reasonable assurance of safety and effectiveness of the
device. FDA is reclassifying this device on its own initiative based on
new information.
DATES: This order is effective September 2, 2014. See further
discussion in section V ``Implementation Strategy'' for compliance
dates.
FOR FURTHER INFORMATION CONTACT: Neil R.P. Ogden, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm.1438, Silver Spring, MD 20993-0002, 301-
796-6397.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) establishes
a comprehensive system for the regulation of medical devices intended
for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval). One type of general control provided by the FD&C Act is a
restriction on the sale, distribution, or use of a device under section
520(e) of the FD&C Act (21 U.S.C. 360j(e)). A restriction under section
520(e) must be implemented through rulemaking procedures, rather than
through the administrative order procedures that apply to this
reclassification under section 513(e) of the FD&C Act, as amended by
the Food and Drug Administration Safety and Innovation Act (FDASIA)
(Pub. L. 112-144).
Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. Applying these procedures, FDA has classified
most preamendments device types.
Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified under section 513(f)(1) of the FD&C Act into
class III without any FDA rulemaking process. Those devices remain in
class III and require premarket approval unless, and until, the device
is classified or reclassified into class I or II under section
513(f)(2) or (f)(3) of the FD&C Act or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
On July 9, 2012, Congress enacted FDASIA. Section 608(a) of FDASIA
amended the device reclassification procedures under section 513(e) of
the FD&C Act, changing the process from rulemaking to an administrative
order. Prior to the issuance of a final order reclassifying a device,
the following must occur: (1) Publication of a proposed order in the
Federal Register; (2) a meeting of a device classification panel
described in section 513(b) of the FD&C Act; and (3) consideration of
comments to a public docket. The proposed reclassification order must
set forth the proposed reclassification and a substantive summary of
the valid scientific evidence concerning the proposed reclassification,
including the public health benefits of the use of the device, and the
nature and incidence (if known) of the risk of the device. (See section
513(e)(1)(A)(i) of the FD&C Act.) FDA issued a proposed
reclassification order for the devices that are the subject of this
final reclassification order on May 9, 2013 (78 FR 27117).
Section 513(e) provides that FDA may, by administrative order,
reclassify a device based upon ``new information.'' FDA can initiate a
reclassification under section 513(e) of the FD&C Act or an interested
person may petition FDA. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland-Rantos
Co. v. United States Department of Health, Education, and Welfare, 587
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence,'' as defined in 21 CFR 860.7(c)(2). (See,
e.g., Gen. Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact
Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied,
474 U.S. 1062 (1986).)
FDA also regulates electronic products, including sunlamp products
[[Page 31206]]
and UV lamps intended for use in sunlamp products, under chapter 5,
subchapter C of the FD&C Act (21 U.S.C. 360hh et seq.). Under these
provisions, FDA administers an electronic product radiation control
program to protect the public health and safety. This authority
provides for developing, amending, and administering radiation safety
performance standards for electronic products. Sunlamp products and UV
lamps intended for use in sunlamp products are subject to the
regulations for electronic product radiation control, including 21 CFR
parts 1000 through 1010 and Sec. 1040.20 (21 CFR 1040.20). The sunlamp
products and UV lamps intended for use in sunlamp products performance
standard in Sec. 1040.20 was originally published in the Federal
Register on November 9, 1979 (44 FR 65352). In the Federal Register of
September 6, 1985 (50 FR 36548), FDA amended Sec. 1040.20 and made it
applicable to all sunlamp products and UV lamps intended for use in
sunlamp products manufactured on or after September 8, 1986. FDA plans
to propose amendments to this performance standard to reflect current
scientific knowledge related to sunlamp product and UV lamp use,
harmonize it more closely with International Electrotechnical
Commission (IEC) International Standard 60335-2-27, Ed. 5.0: 2009-12,
and strengthen the warning statement required by Sec.
1040.20(d)(1)(i), in accordance with the results of the study FDA
conducted under section 230 of the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110-85).
II. Public Comments in Response to the Proposed Order
FDA received over 2,500 comments in response to the proposed order.
Many of these comments supported the proposal. The comments that
expressed concerns raised many of the same issues as one another. The
comments can be categorized in the following six areas: (1) Terminology
and definitions, (2) procedural aspects of the classification, (3)
510(k) notification, (4) special controls, (5) underlying science, and
(6) miscellaneous comments. To make it easier to identify comments and
our response to the comments, the word ``Comment'' appears before the
description of the comment, and the word ``Response'' appears before
our response. We have also numbered each comment to make it easier to
identify a particular comment. The number assigned to each comment is
purely for organizational purposes and does not signify the comment's
value or importance or the order in which it was submitted.
A. Terminology and Definitions
(Comment 1) Why is the Agency using such a broad interpretation of
the term ``sunlamp product'' that includes sunlamp products and UV
lamps? The Agency's treatment of these products as a single class of
product is inconsistent with the performance standard at Sec. 1040.20,
which identifies them as distinct products. By treating them as a
single class of product, FDA is ignoring differences in physical
characteristics between these products.
(Response 1) Prior to this reclassification, UV lamps intended to
tan the skin and sunlamp products incorporating UV lamps were regulated
together under the same classification regulation, Sec. 878.4635 (21
CFR 878.4635), as class I 510(k)-exempt devices (subject to the
limitations in 21 CFR 878.9, Limitations of exemptions from section
510(k) of the Federal Food, Drug, and Cosmetic Act). Manufacturers
appear to have understood that this classification included both
sunlamp products and UV lamps, since they have been listing both
products under the same product code in the Agency's Registration and
Listing database.\1\
---------------------------------------------------------------------------
\1\ See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm product code LEJ.
---------------------------------------------------------------------------
In the proposed reclassification order, FDA proposed to rename the
classification regulation from ``ultraviolet lamps for tanning'' to
``sunlamp products,'' but after considering comments submitted in
response to the proposed order, FDA believes the proposed renaming
would not be sufficiently clear in its inclusion of both sunlamp
products and UV lamps intended for use in sunlamp products. Thus, in
this final order, FDA has renamed the regulation and revised the
definition of the product in Sec. 878.4635(a) to more clearly indicate
that the regulation includes both sunlamp products and UV lamps
intended for use in sunlamp products. This language is consistent with
the terminology used in the performance standard for these products in
Sec. 1040.20.
FDA acknowledges that there are differences between sunlamp
products and UV lamps intended for use in sunlamp products, and so has
made clear in this final order that certain labeling requirements (see
Sec. 878.4635(b)(6)(i)) apply only to sunlamp products whereas other
labeling requirements (see Sec. 878.4635(b)(6)(ii)) apply to both
sunlamp products and and UV lamps intended for use in sunlamp products.
Further, FDA is requiring that the labeling special control at Sec.
878.4635(b)(6)(i)(A) be placed in a black box. For devices that have
significant risks that would make the devices unsafe if used
inappropriately, FDA may require that the risks be explained in warning
statements placed in a black box that is displayed prominently in the
labeling to ensure awareness by the end user. In conjunction with other
regulatory controls, awareness of these important risks by the end user
enables these devices to be used safely. In this case, a prominent
black box warning that identifies individuals who should not use the
device is necessary to allow sunlamp products to be used safely.
B. Procedural Aspects of Classification
(Comment 2) The proposed order cites several studies that were
published subsequent to the March 2010 General and Plastic Surgery
Advisory Panel (the ``panel''), underscoring the evolving science in
this space. By not convening a new panel, is the Agency denying
stakeholders a fair opportunity to address the methodology or other
concerns related to studies on which the Agency is relying to take this
action? Further, by failing to convene a panel, is the Agency failing
to rely on up-to-date medical research?
(Response 2) The 2010 panel considered all relevant scientific
issues associated with sunlamp products and UV lamps intended for use
in sunlamp products and recommended upclassifying these devices. FDA is
not aware of any significant changes in benefits or risks relating to
sunlamp products and UV lamps intended for use in sunlamp products that
have been identified in the scientific literature since the 2010 panel
meeting. The articles published since that meeting offer further
support for the panel's recommendation.
Of the 53 references cited in the proposed order, only 4 are
scientific articles published after the 2010 panel. Although these four
articles were published after the panel met to discuss reclassification
of sunlamp products and UV lamps intended for use in sunlamp products,
the substance therein is not ``new'' as it relates to issues considered
at the 2010 panel. Specifically:
Although Reference 1 (Reference 15 in the proposed order)
was published after the panel meeting, its conclusion--that users with
a history of melanoma are at an increased risk for melanoma
reoccurrence--is also discussed in research published in 2006 by
[[Page 31207]]
Freedman, et al. (Ref. 2), which was known at the time of the panel
meeting.
References 3 and 4 (References 18 and 19 in the proposed
order) discuss the effects of tanning in childhood and early adult
life, which were discussed extensively by the panel. Some panel members
favored an age restriction for indoor tanning (i.e., individuals under
a certain age would not be permitted to use sunlamp products and UV
lamps intended for use in sunlamp products) and thought that the cutoff
age should be 18.
As discussed in the proposed order, Reference 5 (Reference
28 in the proposed order) showed that, despite protective measures
instituted in commercial tanning facilities, 66 percent of female
college-age users reported skin erythema from indoor tanning, and these
users reported one episode of sunburn out of every five tanning
sessions. These findings are consistent with an earlier report (Ref. 6)
(Reference 29 in the proposed order) published in 2009 that showed that
58 percent of adolescent indoor tanners had experienced sunburns from
exposure to sunlamp products and UV lamps intended for use in sunlamp
products.
Stakeholders had an opportunity to raise concerns relating to the
underlying methodology of any studies FDA relied on in the proposed
order in their comments on that proposed order. We have addressed such
comments in the subsection ``E. Underlying Science'' in this document.
(Comment 3) Using a panel meeting that took place prior to the
issuance of the proposed reclassification order violates the sequence
of events for issuing an administrative order to change the
classification of a device as prescribed by section 513(e) of the FD&C
Act, as amended by FDASIA.
(Response 3) The process followed by FDA in reclassifying these
devices is in accordance with the applicable statutory provisions,
which were recently amended by FDASIA. Section 608 of FDASIA amended
section 513(e) of the FD&C Act by changing the reclassification process
from rulemaking to an administrative order process. The amendments to
section 513(e) of the FD&C Act made by FDASIA, require, in relevant
part, that issuance of an administrative order reclassifying a device
be preceded by a proposed order and a meeting of a device
classification panel.
As amended, this section of the FD&C Act does not prescribe when
these two events (the panel meeting and proposed order) must occur in
relation to each other. Therefore, this provision provides the Agency
with the flexibility to hold a panel meeting either before or after the
issuance of a proposed reclassification order. This approach is
consistent with the prior panel provision in section 513(e), which
provided for FDA, at its discretion, to secure a panel recommendation
prior to the promulgation of a reclassification rule and reflects
longstanding practice. Indeed, prior to FDASIA, when a panel meeting
was discretionary, FDA often held a panel meeting prior to proposing
reclassification of a device, for example, when the Agency determined
that a recommendation from the panel would help inform whether
proposing reclassification for the device was appropriate. FDA believes
its interpretation of section 513(e), as amended by FDASIA, is
reasonable and allows the Agency to carry out the reclassification of
devices in the most efficient and effective manner for the Agency and
all stakeholders.
FDA believes the panel's deliberations and recommendations from the
meeting held in March 2010 concerning potential changes to the current
classification or regulatory controls for sunlamp products and UV lamps
intended for use in sunlamp products remain relevant and fully satisfy
the requirements in section 513(e) of the FD&C Act. As explained in the
proposed reclassification order (Ref. 7), ``No significant changes in
risks relating to [sunlamp products and UV lamps intended for use in
sunlamp products] have been identified in the scientific literature
since the 2010 panel meeting; the same risks identified prior to the
2010 panel meeting continue to be presented in literature.'' Therefore,
convening another panel meeting on the reclassification of sunlamp
products and UV lamps intended for use in sunlamp products would be
unnecessarily duplicative and an inefficient use of the time and
resources of all relevant parties.
(Comment 4) Comments were submitted to the record in connection
with the 2010 panel meeting, including a scientific critique of the
scientific papers on which FDA had relied. FDA's proposed order fails
to address or discuss the scientific submissions made by the
stakeholders. Did FDA take these submissions into account, and, if so,
how were they addressed in the proposed order?
(Response 4) Stakeholders submitted 139 comments to the docket for
the 2010 panel meeting (Docket No. FDA-2009-N-0606). Although FDA's
proposed order does not directly discuss each specific comment, the
Agency did review and consider all received comments in the development
of its proposed reclassification of sunlamp products and ultraviolet
lamps intended for use in sunlamp products. The proposed order includes
the following summary of the comments ``The majority of the input
received via the open public docket supported strengthening FDA's
regulation of these devices. Although many comments did not expressly
specify whether regulation of sunlamps should be strengthened or not,
because most of these were related to the experiences of people with
melanoma, FDA interpreted them to be in support of stricter regulation
of sunlamps. Six comments of 139 total comments took the position that
FDA should not change its current regulation of indoor tanning devices.
Overall, the docket comments strongly paralleled the opinions of the
panel members (Ref. 7).''
FDA considered not only the comments received in the docket to the
2010 panel meeting, but also relevant scientific literature, both in
favor of and against the use of sunlamp products. As required by
section 513(e) of the FD&C Act, as amended by FDASIA, the proposed
order provided a substantive summary of the valid scientific evidence
concerning the proposed reclassification of the device, including the
available information on the benefits of use of sunlamp products, as
well as the risks to health from use of these products. The proposed
order also called for comments from any interested stakeholders. The
comment period on the proposed order closed on August 7, 2013. All
comments received were considered by the Agency prior to development of
this final reclassification order.
(Comment 5) The 2010 panel was not representative of industry and
certain members of the panel had a conflict of interest because they
were partnered with the American Academy of Dermatology (AAD).
(Response 5) Advisory committees provide FDA with independent
advice from outside experts. FDA's advisory committee program is
governed by a number of Federal laws and regulations that set forth
standards for convening advisory committees and reviewing potential
conflicts of interest. FDA remains committed to ensuring that its
advisory committee process is conducted according to applicable
statutes and regulations and consistent with relevant FDA guidance.
These laws, regulations, and guidance documents are available on our
Web site, and provide ready access to the statutory and regulatory
framework that FDA advisory committees operate
[[Page 31208]]
within and describe the steps that FDA has taken to enhance
decisionmaking, increase transparency, and strengthen public confidence
in our advisory committee program.
FDA disagrees with the comment that the composition of the 2010
panel was flawed. A copy of the panel roster can be found at the FDA's
Web site (Ref. 8). The 2010 panel members were screened for potential
or actual conflicts of interest in accordance with legal requirements
and consistent with FDA guidance, and were cleared by the Agency to
participate at the meeting.\2\ As indicated on the panel roster, there
was a consumer representative, an industry representative, and a
patient representative on the 16-person panel.
---------------------------------------------------------------------------
\2\ See https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf.
---------------------------------------------------------------------------
(Comment 6) Prior to the 2012 enactment of FDASIA, classifications
under section 513(e) of the FD&C Act were governed by the Federal
rulemaking process requiring economic analysis of any proposed
regulations. At any time after the Agency commenced its
reclassification efforts with respect to sunlamp products and UV lamps
intended for use in sunlamp products in 2009, did the Agency undertake
any formal or informal economic analysis of possible changes to the
regulation of this product?
(Response 6) The Federal rulemaking process requires economic
analysis of proposed rules under Executive Order 12866. Section 608 of
FDASIA amended section 513(e) of the FD&C Act by changing the
reclassification process from rulemaking to an administrative order
process. This order process is not subject to Executive Order 12866.
Therefore, although the Agency considered the impact on stakeholders
and the least burdensome method to secure a reasonable assurance of
safety and effectiveness for sunlamp products and UV lamps intended for
use in sunlamp products, the Agency has not conducted an economic
analysis for reclassification of these devices.
FDA did consider the impact that this reclassification may have on
small businesses and has decided to employ a staged implementation plan
to minimize the burden on affected entities. Small businesses play an
important role in the medical device industry and are responsible for
more than half of all medical devices under development, including
sunlamp products and UV lamps intended for use in sunlamp products.
Given this role, FDA recognizes how critical it is that small firms
understand the regulatory landscape in order to meet regulatory
requirements for marketing. The Division of Industry and Consumer
Education (DICE) in the Center for Devices and Radiological Health
(CDRH) is dedicated to helping small businesses successfully navigate
the Agency's device approval and clearance processes. In addition,
small businesses may qualify for substantially discounted user fees--a
510(k) submission fee for a small business in FY 2014 is $2,585, which
is half the standard 510(k) submission fee.
(Comment 7) Because FDA has not disclosed what the Agency will
ultimately require under amendments to Sec. 1040.20, industry cannot
adequately comment on the proposed reclassification order.
(Response 7) Manufacturers must comply with the requirements set
forth in Sec. 1040.20. If, in the future, Sec. 1040.20 is updated, as
FDA has announced its intent to do, it will be done through its own
notice and comment rulemaking process and stakeholders will be provided
the opportunity to comment during that process.
(Comment 8) FDA should update the requirements in Sec. 1040.20
prior to the implementation of this reclassification because 510(k)s
for these products that are submitted prior to the performance standard
amendments would not necessarily comply with the performance standard
and could require manufacturers to have to submit additional 510(k)s
for their products.
(Response 8) With respect to Sec. 1040.20, manufacturers must
comply with the performance standard in effect at the time of the
510(k) submission. If the performance standard is amended,
manufacturers would not need to submit a new 510(k) unless there are
significant changes to the device that trigger the need for a new
510(k) submission under 21 CFR 807.81(a)(3) (see FDA's guidance
``Deciding When to Submit a 510(k) for a Change to an Existing Device''
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm)).
C. 510(k) Notification
(Comment 9) Has FDA conducted any analysis of the increased
resources it will need to enforce these new regulations, including the
demands placed on the Agency to review 510(k) premarket notifications?
(Response 9) A review of FDA's Establishment Registration and
Device Listing database, which identifies, among other things,
manufacturers that are registered to market medical devices and the
devices that they currently market, shows that there are approximately
25 firms registered as sunlamp product manufacturers or manufacturers
of UV lamps intended for use in sunlamps products. To continue offering
these devices for sale, a 510(k) must be submitted by August 26, 2015,
(see further discussion in section V ``Implementation Strategy'').
Thus, FDA expects to receive approximately 25 510(k) submissions within
this timeframe (and potentially a few other 510(k) submissions for new
sunlamp products and UV lamps intended for use in sunlamp products).
FDA typically receives and reviews approximately 4,000 510(k)
submissions each year, so the Agency does not expect the
reclassification of sunlamp products and UV lamps intended for use in
sunlamp products to significantly affect review times or resources.
As a part of the Medical Device User Fee Amendments of 2012, or
MDUFA III, FDA committed to meeting certain review times for 510(k)
submissions. FDA's current review goal for 510(k) submissions is to
make a substantial equivalence determination within 90 days of active
FDA review. The latest published review data from January 29, 2014,
shows that FDA has met its review goal for 100 percent of the 510(k)
submissions received in fiscal year 2014, to date. FDA expects to meet
these review goals for any 510(k) submission for sunlamp products or UV
lamps intended for use in sunlamp products (Ref. 9).
(Comment 10) Can the Agency clarify by when it expects
manufacturers to submit a 510(k) notification for products already
being offered for sale, and whether those products can continue to be
offered for sale after submission of the 510(k) notification but prior
to Agency clearance?
(Response 10) Manufacturers of sunlamp products or UV lamps
intended for use in sunlamp products that are offered for sale prior to
September 2, 2014, must submit a 510(k) and comply with the labeling
special controls established in this final order by August 26, 2015,
which is 15 months from the date of publication of this final order
(see section V ``Implementation Strategy'') for any device they wish to
continue offering for sale. Manufacturers can continue offering these
products for sale while FDA reviews the 510(k) submissions. However, if
a 510(k) is not submitted or the device is not in compliance with the
labeling special controls by this date, or if FDA determines after
review of the 510(k) that the device is not substantially equivalent to
a legally marketed predicate device or the device is not in compliance
with the labeling
[[Page 31209]]
or other special controls, the device, including individual devices
already in use, would be adulterated and misbranded under sections
501(f)(1)(B) and 502(o) of the FD&C Act, and the manufacturer would
have to cease offering the device for sale.
(Comment 11) The proposed order is silent on the status of products
that are already on the market for which the manufacturer is no longer
in business or for which it is not economically viable for the
manufacturer to incur the costs associated with submitting a 510(k).
(Response 11) Individual sunlamp products that have already been
sold to end users prior to September 2, 2014, the model of which has
been discontinued or is otherwise no longer marketed after this date,
do not have to have 510(k)s or comply with the non-labeling special
controls, but they must comply with the labeling special controls at
Sec. 878.4635(b)(6)(i)(A) by August 26, 2015. If the manufacturer is
no longer in business, sunlamp product owners would have to apply the
required labeling to sunlamp products to keep these devices in
compliance with the labeling requirements.
(Comment 12) Is one 510(k) required for a ``sunlamp product,''
which by definition includes a fixture and UV lamp, or are separate
510(k)s required for the sunlamp product and UV lamp? Similarly, if UV
lamps are sold with a sunlamp product and on their own, do multiple
510(k)s need to be submitted?
(Response 12) In this final order, FDA has revised the
classification identification to expressly include ``sunlamp products''
and ``UV lamps intended for use in sunlamp products'' and has included
revised definitions of these devices, as discussed in response to
Comment 1. A 510(k) submission is required for sunlamp products and for
UV lamps intended for use in sunlamp products. If a UV lamp intended
for use in a sunlamp product is sold with a sunlamp product or they are
sold separately from one another, then both devices can be included in
the same 510(k) submission. For more information on this issue, please
see FDA Guidance, ``Bundling Multiple Devices or Multiple Indications
in a Single Submission,'' available at https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089731.htm.
(Comment 13) If FDA is requiring that UV lamp manufacturers submit
510(k)s for their lamps, are lamp manufacturers required to submit
separate 510(k)s for use of their lamps in each tanning bed or booth?
Or, can UV lamp manufacturers that are required to submit 510(k)s for
their lamps do so without referencing use of the lamp with a particular
tanning bed or booth? Is a replacement UV lamp manufacturer required to
submit a separate 510(k) for use of each replacement lamp type in each
possible tanning bed or tanning booth in which the replacement lamp
could conceivably be used?
(Response 13) Manufacturers of UV lamps that submit a 510(k) do not
need to submit a separate 510(k) for use of each replacement lamp type
in each possible tanning bed or tanning booth in which the replacement
lamp could conceivably be used, but they should specify in their 510(k)
submission the design characteristics of the sunlamp product with which
the lamp is compatible.
(Comment 14) If FDA is requiring that all UV lamp manufacturers,
including replacement lamp manufacturers, submit 510(k)s, is a
manufacturer of replacement UV lamps required to submit a separate
510(k) for each of its lamp types? Will the Agency accept 510(k)s for
lamp model families?
(Response 14) Instead of submitting separate 510(k)s for different
lamp types, a manufacturer can submit a ``bundled'' 510(k) for related
lamps. For more information on this issue, please see FDA Guidance,
``Bundling Multiple Devices or Multiple Indications in a Single
Submission,'' available at https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089731.htm.
(Comment 15) Sunlamp product and UV lamp manufacturers are aware of
cleared 510(k)s for ``UV lamps for tanning,'' but at least some of
these 510(k)s are over 20 years old. Over the past 20 years, sunlamp
products and UV lamps have improved substantially with regard to
performance and safety. Sunlamp product and UV lamp manufacturers are
uncertain how to show substantial equivalence to one of the 20-year-old
sunlamp products or UV lamps given these significant improvements.
(Response 15) FDA will find a contemporary sunlamp product or UV
lamp intended for use in a sunlamp product to be substantially
equivalent to a predicate device if the contemporary device: (1) Has
the same intended use as the predicate device and (2) has the same
technological characteristics as the predicate device or has different
technological characteristics but is at least as safe and effective as
the predicate device and does not raise new questions of safety or
effectiveness. If the device has different technological
characteristics from the predicate device, the 510(k) submission must
include a summary of how the technological characteristics of the
device compare to a legally marketed predicate device (21 CFR
807.92(a)(6)). In addition to showing substantial equivalence,
manufacturers of new sunlamp products will need to show compliance with
the special controls required under this order.
(Comment 16) FDA should ``grandfather'' in all currently legally
marketed sunlamp products, such that they would not be subject to the
requirements set forth in this order. Moreover, these products should
be allowed to be used as predicate devices as long as the manufacturers
provide adequate documentation that the products meet all requirements
necessary for a 510(k) submission.
(Response 16) Manufacturers of sunlamp products or UV lamps
intended for use in sunlamp products that are offered for sale prior to
September 2, 2014, are required to submit 510(k)s and must comply with
the labeling special controls by August 26, 2015, for any device they
wish to continue offering for sale. Any sunlamp product or UV lamp
intended for use in a sunlamp product legally marketed on or before
September 2, 2014, including both 510(k)-cleared and 510(k)-exempt
devices, can be used as a predicate device in a 510(k). A 510(k) for
such a device must demonstrate that the device was legally offered for
sale on or before September 2, 2014, and it must comply with the
special controls.
D. Special Controls
(Comment 17) Many of the proposed special controls are either
unrelated to UV lamps intended to be used with sunlamp products or are
impossible for UV lamp manufacturers to achieve without involvement of
a tanning bed or tanning booth. For example, UV lamps do not come into
contact with indoor tanners due to safety issues associated with heat
generation and possible lamp breakage. Given this, how would UV lamp
manufacturers conduct biocompatibility testing or comply with some of
the other special controls that may apply only to sunlamp products?
(Response 17) If a certain non-labeling special control does not,
as a practical matter, apply to a device due to the device's nature or
design, manufacturers may meet such special control by explaining such
practical inapplicability in their 510(k) submission to FDA. For
example, biocompatibility testing would not apply to a UV lamp that
does not contact the human body and the software verification
requirement would not apply to a UV lamp that does not employ software.
As long as FDA finds such justification acceptable, the
[[Page 31210]]
manufacturer would not have to conduct or submit any testing that would
otherwise be required by that particular special control. FDA has
chosen this flexible approach, as opposed to assigning certain special
controls to certain types of sunlamp products and UV lamps intended for
use in sunlamp products, to account for ever-changing technology in
this area.
(Comment 18) FDA's proposed reclassification order would require
that certain warning labeling appear on ``sunlamp product fixtures.''
Given that FDA specifies that the warning must appear on ``sunlamp
product fixtures,'' does this special control apply to UV lamps?
(Response 18) Based on comments we received, we have clarified the
applicability of the labeling requirements in the final order. The
labeling in Sec. 878.4635(b)(6)(i) pertains only to sunlamp products
while the labeling in Sec. 878.4635(b)(6)(ii) pertains to sunlamp
products and UV lamps intended for use in sunlamp products. This means
that sunlamp products must comply with the requirements in Sec.
878.4635(b)(6)(i) and (b)(6)(ii), while UV lamps intended for use in
sunlamp products must comply with Sec. 878.4635(b)(6)(ii) and not with
Sec. 878.4635(b)(6)(i).
(Comment 19) A font height of 10 millimeters (mm) is too small for
the labeling prescribed in proposed Sec. 878.4635(b)(6)(i).
(Response 19) FDA believes 10 mm is sufficient height to attract
attention and warn prospective users that individuals under age 18
should not use the device. Ten mm is a minimum; labels are permitted to
display font greater than 10 mm.
E. Underlying Science
(Comment 20) The recent information cited by FDA in the proposed
reclassification order is comprised solely of recent reviews of
information that has been available for several years, and this
information does not compel a change to the current classification or
performance standards.
(Response 20) The articles referenced in the proposed order qualify
as ``new information'' under section 513(e) of the FD&C Act. The term
``new information,'' as used in section 513(e) of the FD&C Act,
includes information developed as a result of a reevaluation of the
data before the Agency when the device was originally classified, as
well as information not presented, not available, or not developed at
that time. (See, e.g., Holland-Rantos Co. v. United States Department
of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir.
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard,
366 F.2d 177 (7th Cir. 1966).). The sources cited in the proposed
reclassification order are all encompassed by this definition and
reveal, among other things, that UV radiation is a significant
contributing factor in developing skin cancer, that the number of
females exposed to indoor UV radiation who are diagnosed with skin
cancer is increasing, and that individuals under 18 who are exposed to
UV radiation are at an increased risk of developing skin cancer. As
stated in the proposed order, the cumulative effects of UV radiation
exposure have been linked to higher incidence of skin cancer (Ref. 10).
Moreover, individuals under 18 are particularly vulnerable to the
damaging effect of UV radiation. According to a 2008 article
recommending an age restriction to prevent sunlamp product use in
children and teenagers, a number of biological factors are identified
as potentially causing the increase in the risk of developing melanoma
from exposure to sunlamps during those years (Ref. 11). These findings
have compelled a change in how FDA regulates these devices.
(Comment 21) Sunlamp products can stimulate the body to produce
vitamin D. In addition to bone problems and increased cancer risk,
vitamin D deficiency has been linked to a heightened risk of Type 1
diabetes, multiple sclerosis and other autoimmune diseases, infectious
diseases such as influenza and tuberculosis, and high blood pressure.
For these reasons, additional regulation of sunlamp products is not
appropriate.
(Response 21) FDA agrees that vitamin D is critical for the body's
health. In the proposed order, FDA acknowledged that UV radiation
stimulates the body's production of vitamin D, however, there are safer
alternatives to obtain vitamin D other than the use of sunlamp products
and UV lamps intended to be used in sunlamp products, for example,
through an individual's diet (Ref. 12). As stated previously, FDA
believes that additional regulation is necessary to provide a
reasonable assurance of safety and effectiveness of these devices.
(Comment 22) FDA should not rely on the International Agency for
Research on Cancer's (IARC) study (Ref. 13) to support this
reclassification because that study included outdoor sun exposure and
dermatology exposure, which confounded the data and exaggerated the
effects of UV radiation.
(Response 22) As with most indoor tanning risk studies, it can be
difficult to discern for each subject the relative amounts of indoor
and outdoor UV exposure. However, previous use of a sunlamp product and
frequency of use can be assessed to determine relative risk of indoor
tanning exposure. All of the studies analyzed in the IARC study focused
on indoor tanning and melanoma as well as other skin cancers such as
basal cell carcinoma and squamous cell carcinoma. FDA believes the IARC
report's conclusions are applicable to indoor tanning.
(Comment 23) Even though women's use of indoor tanning devices has
increased in recent years, SEER cancer incidence data shows that the
incidence of melanoma has decreased from 5.0 in 1975-1982 to 2.3 in
1981-2010 in females (Ref. 14). This finding undermines the argument
that indoor tanning causes melanoma.
(Response 23) The SEER incidence data referenced in the comment is
incorrect. In the SEER data, an increase in the incidence of melanoma
in females has been noted since 1975 and has not abated. The age
adjusted rates of melanoma for females per 100,000 are as follows (Ref.
15):
Table 1
------------------------------------------------------------------------
SEER Melanoma
incidence
Year per 100,000
females
------------------------------------------------------------------------
1975.................................................... 7.44
1980.................................................... 9.63
1985.................................................... 11.16
1990.................................................... 11.84
1995.................................................... 13.81
2000.................................................... 15.50
2005.................................................... 18.41
2010.................................................... 19.30
------------------------------------------------------------------------
The increase in melanoma incidence among white females is even
greater (Ref. 15):
Table 2
------------------------------------------------------------------------
SEER melanoma
incidence
Year per 100,000
white females
------------------------------------------------------------------------
1975.................................................... 8.21
1980.................................................... 11.12
1985.................................................... 12.70
1990.................................................... 13.93
1995.................................................... 16.47
2000.................................................... 19.08
2005.................................................... 23.14
2010.................................................... 24.23
------------------------------------------------------------------------
(Comment 24) The IARC report shows only a \1/10\ of 1 percent
increase in risk of melanoma. The IARC report clearly
[[Page 31211]]
states that epidemiologic studies do not support a consistent
relationship between tanning and cancer.
(Response 24) FDA is unaware of the source of the \1/10\ of 1
percent value referenced by the commenter. Rather, the IARC report
identified a causal relationship between indoor tanning and melanoma
risk based on evidence pertaining to the strength, consistency, dose-
response and temporal sequence of the association of the use of sunlamp
products with melanoma risk, and of the coherence and biologic
plausibility of the association (Ref. 13). Additionally, the study
found that first exposure to sunlamp products before age 35 increased
the risk of melanoma by 75 percent compared to individuals that never
used sunlamp products.
(Comment 25) The cause of melanoma is unknown, although most
scientists believe the primary cause is genetic in nature. The personal
risk factors for melanoma include red hair, extremely pale skin that
will not tan, presence of moles and freckles on the body, and a family
history of melanoma. Upclassifying these devices, and limiting exposure
to UV radiation, is not necessary for those without a genetic
predisposition to melanoma.
(Response 25) Although personal risk factors can also contribute to
the risk for melanoma, there have been multiple studies which have
found that sunlamp product use increases the risk of melanoma. Meta
analyses by Gallagher et al. (Ref. 16), IARC (Ref. 13), and Boniol et
al. (Ref. 17) have all found a link between sunlamp product use and
melanoma.
(Comment 26) The literature is replete with conflicting
information, including science suggesting that moderate, non-burning UV
exposure reduces the risk of melanoma and that sunburn is the relevant
exposure circumstance to be avoided, whether the UV comes from the sun
or from a tanning bed, and whether the person is older or younger than
18. Sunburn prevention as the correct approach is supported by research
showing that biologically, sunburn affects the skin differently when
compared to non-burning UV exposure. Sunburning should be avoided, but
moderate exposure by individuals--regardless of the user's age--is not
risky.
(Response 26) As stated in FDA's proposed order to reclassify these
devices, there is no evidence that moderate non-burning UV exposure or
attaining a ``base tan'' provides any protection against premature
aging of the skin or reduces the risk of skin cancer (Ref. 7). The
Agency concurs with the comment that there are other risk factors for
melanoma besides sunbed use.
(Comment 27) Dr. David G. Hoel, 1 of the 20 scientists that were
called upon by the IARC in 2009 to reassess the carcinogenicity of all
forms of radiation, has written a report stating that the 2006 IARC
conclusion that there is a 75 percent increase in melanoma risk when
tanning starts before age 35 is invalid. Dr. Hoel is preparing an
article for publication on the subjects of melanoma, UV radiation, and
the IARC report. The purpose of this article is to correct the many
misconceptions about the science regarding UV radiation and melanoma
that have been promoted by the AAD and other anti-tanning advocates.
Dr. Hoel argues that the significant differences between regulatory
standards in the United States and Europe with regard to use of sunlamp
products make the predominantly European data in the IARC report an
inappropriate basis for the FDA's decision to change the controls
applicable to sunlamp products in the United States.
(Response 27) The paper alluded to has not been published or
undergone peer review. Studies subsequent to the IARC study have
corroborated that study's findings that there is a correlation between
melanoma and sunlamp product use. For example, a meta-analysis
employing data from numerous studies found an increased risk of
melanoma with sunlamp product use (Ref. 17). Furthermore, this study
noted that the magnitude of the increased risk was greater when sunlamp
product use began earlier in life. In addition, Dor[eacute] and Chignol
observed that two studies in Minnesota and Australia found an increased
risk of melanoma with indoor tanning (Ref. 18). They also observed a
very large study of Norwegian and Swedish women that found an increased
risk of melanoma with indoor tanning.
(Comment 28) After further analysis of the IARC report, Dr. Mia
Papas and Dr. Anne Chappelle published a peer-reviewed report (Ref. 19)
criticizing the IARC report for not differentiating among Medical
Phototherapy Equipment, Unsupervised Home Equipment, and Commercial
Tanning Salon Equipment. Their article indicates that there is no
association between sunlamp product use and melanoma if you remove home
use and medical use of sunlamp products from the analysis. Therefore,
the report being used to support the reclassification is flawed.
(Response 28) This literature (Ref. 19) has not been published in a
peer-reviewed journal, despite the commenter's assertion to the
contrary. In the peer-reviewed journal ``Cancer Epidemiology,
Biomarkers & Prevention,'' Gallagher et al. (Ref. 16) noted that the
results from studies subsequent to the IARC report, taken together, do
not differ in character from those seen in the earlier studies. During
earlier studies, home use of sunlamp products was greater than it is
now. During later studies, the proportion of the sunlamp product use at
indoor tanning facilities increased greatly, but according to Gallagher
et al. (Ref. 16), melanoma incidence did not markedly differ,
supporting the conclusion that the risk from use of sunlamp products at
tanning facilities does not differ markedly from the risks of home use
of such devices.
(Comment 29) An article written by William Grant (Ref. 20)
indicated that the 50 subjects in the IARC report were primarily skin
type 1. Skin type 1 individuals have a natural increased risk to skin
cancer and because tanning facilities do not tan skin type 1's, this
skewed the data in the IARC report.
(Response 29) The Grant critique (Ref. 20) points out that fair
skinned individuals are more likely than other individuals to develop
skin cancer due to UV exposure. However, UV radiation exposure from
indoor tanning use increases the risk of skin cancer regardless of
whether individuals have high or low pigmentation (Ref. 21). For this
reason, FDA has not changed its position regarding the link between
sunlamp product use and skin cancer. It is also important to note that
a significant portion of the U.S. population is skin type 1 and may use
sunlamp products (Ref. 22).
F. Miscellaneous
(Comment 30) Unless tanning beds for home use are banned, this
reclassification does not make sense.
(Response 30) The commenter did not provide a justification for
this conclusion, so we are not completely clear as to the basis for
this comment. However, we emphasize that the new 510(k) requirements
and special controls (including labeling) set forth in this final order
apply to all sunlamp products and UV lamps intended to be used in
sunlamp products, including ones sold to individuals for home use. FDA
believes that the regulatory controls set forth in this order are
necessary to provide a reasonable assurance of safety and effectiveness
for these devices.
(Comment 31) Regulated tanning facilities are a safer alternative
than home tanning where there are no informed workers. Tanning facility
[[Page 31212]]
owners are trained and educated to protect clients who want to tan.
(Response 31) This final order does not distinguish between devices
sold for use at home and devices sold to tanning facilities; the
regulatory controls set forth in this order apply to both.
(Comment 32) People who have prescriptions for dermatological
disorders will be burdened by this reclassification.
(Response 32) Devices prescribed for individuals with
dermatological disorders have been and will continue to be regulated
differently from devices regulated under Sec. 878.4635. UV lamps for
dermatological disorders have long been class II medical devices
regulated under 21 CFR 878.4630 and are unaffected by this
reclassification.
III. The Final Order
Under section 513(e) of the FD&C Act, FDA is adopting its findings
as published in the preamble to the proposed order. FDA is issuing this
final order to reclassify UV lamps used to tan the skin from class I
(general controls) exempt from premarket notification to class II
(special controls) and subject to premarket notification and rename
them sunlamp products and UV lamps intended for use in sunlamp
products.
IV. Premarket Notification
Class II devices are subject to the 510(k) premarket notification
requirement unless exempted under section 510(m) of the FD&C Act. Under
this reclassification, the Agency is not exempting these devices from
premarket notification (510(k)) submission requirements as provided for
under section 510(m) of the FD&C Act. The premarket notification
requirement allows the Agency to review the technological
characteristics, performance, intended use(s), and labeling of medical
devices to ensure the devices are substantially equivalent to legally
marketed predicate devices before they enter the market. Substantial
equivalence requires that a new device must have: (1) The same intended
use as legally marketed predicates and (2) either the same
technological characteristics as a legally marketed predicate, or if
there are significant differences, the differences must not raise new
questions of safety and effectiveness and the performance data must
demonstrate that the new device is at least as safe and effective as
the legally marketed predicate device. (See section 513(i) of the FD&C
Act.) This assures that new devices that differ significantly in terms
of safety and effectiveness from predicate devices already legally on
the market will be subject to the more rigorous premarket approval
requirement.
FDA cleared several 510(k)s for sunlamp products prior to exempting
the devices from premarket notification submission.\3\ At least one
510(k) for a sunlamp product has been cleared since then under product
code LEJ. These cleared sunlamp products, as well as any 510(k)-exempt
sunlamp product or UV lamp intended for use in a sunlamp product
legally offered for sale on or before September 2, 2014, can serve as
predicates for substantial equivalence purposes.
---------------------------------------------------------------------------
\3\ See 59 FR 63005 (December 7, 1994).
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V. Implementation Strategy
Based on comments on the proposed order regarding our
implementation strategy, we are clarifying the compliance dates for the
various requirements set forth in this final order. For additional
information on this issue, see the DATES heading of this final order.
Models of sunlamp products and UV lamps intended for use
in sunlamp products that have not been offered for sale prior to
September 2, 2014, or have been offered for sale but are required to
submit a new 510(k) under Sec. 807.81(a)(3) because the device is
about to be significantly changed or modified: \4\ Manufacturers must
obtain 510(k) clearance before marketing the new or changed device.
---------------------------------------------------------------------------
\4\ See FDA's guidance, ``Deciding When to Submit a 510(k) for a
Change to an Existing Device,'' (available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm), for additional guidance on whether a device change
or modification requires a 510(k) submission.
---------------------------------------------------------------------------
Models of sunlamp products and UV lamps intended for use
in sunlamp products that have been offered for sale prior to September
2, 2014, and continue to be offered for sale after this date:
Manufacturers must submit a 510(k) and comply with labeling special
controls by August 26, 2015, for any device they wish to continue
offering for sale. If a 510(k) is not submitted by this date or the
device is not in compliance with the labeling special controls or if
FDA determines after review of the 510(k) that either the device is not
substantially equivalent to a legally marketed predicate or the device
is not in compliance with the labeling or other special controls, the
device model would be adulterated and misbranded, and offering the
device for sale would have to cease.
Individual sunlamp products that have been shipped to
operators or users such as tanning facilities and individual consumers
prior to September 2, 2014, the model of which has been discontinued or
is otherwise no longer offered for sale: These devices must comply with
the labeling special controls at Sec. 878.4635(b)(6)(i)(A) by August
26, 2015. If the manufacturer is no longer in business, sunlamp product
owners would have to apply the required labeling to keep these devices
in compliance with the labeling requirements.
VI. Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this
reclassification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
VII. Paperwork Reduction Act of 1995
This final order refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in part 807, subpart E, have been
approved under OMB control number 0910-0120 and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.
In addition, FDA concludes that the labeling statements in Sec.
878.4635(b)(6)(i)(A) and (b)(6)(ii)(A) through (b)(6)(ii)(D) do not
constitute a ''collection of information'' under the PRA. Rather, the
labeling statements are ''public disclosure of information originally
supplied by the Federal Government to the recipient for the purpose of
disclosure to the public.'' (5 CFR 1320.3(c)(2)).
VIII. Codification of Orders
Prior to the amendments by FDASIA, section 513(e) provided for FDA
to issue regulations to reclassify devices. Although section 513(e) as
amended requires FDA to issue final orders rather than regulations,
FDASIA also provides for FDA to revoke previously issued regulations by
order. FDA will continue to codify classifications and
reclassifications in the Code of Federal Regulations (CFR). Changes
resulting from final orders will appear in the CFR as changes to
codified classification determinations or as newly codified orders.
Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by
FDASIA, in this final order, we are revoking the requirements in
[[Page 31213]]
Sec. 878.4635 related to the classification of UV lamps for tanning as
class I devices and codifying the reclassification of sunlamp products
and UV lamps intended for use in sunlamp products into class II.
IX. References
FDA has placed the following references on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. Interested persons may see
them between 9 a.m. and 4 p.m., Monday through Friday, and online at
https://www.regulations.gov. (FDA has verified all the Web site
addresses in this reference section, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
1. Salama, A.K., N. de Rosa, R.P. Scheri, et al., ``Hazard-Rate
Analysis and Patterns of Recurrence in Early Stage Melanoma: Moving
Towards a Rationally Designed Surveillance Strategy,'' PLoS One,
vol. 8, pp. e576-e665, 2013.
2. Freedman, D.B., B.A. Miller, and M.A. Tucker, ``New Malignancies
Following Melanoma of Skin, Eye Melanoma, and Nonmelanoma Eye
Cancer,'' New Malignancies Among Cancer Survivors: SEER Cancer
Registries, 1973-2000, pp. 339-362, 2006.
3. Reed, K.B., J.D. Brewer, C.M. Lohse, et al., ``Increasing
Incidence of Melanoma Among Young Adults: An Epidemiological Study
in Olmsted County, Minnesota,'' Mayo Clinic Proceedings, vol. 87,
pp. 328-334, 2012.
4. Cust, A.E., B.K. Armstrong, C. Goumas, et al., ``Sunbed Use
During Adolescence and Early Adulthood Is Associated With Increased
Risk of Early-Onset Melanoma,'' International Journal of Cancer,
vol. 128, pp. 2425-2435, 2011.
5. Stapleton, J.L., J. Hillhouse, R. Turrisi, et al., ``Erythema and
Ultraviolet Tanning: Findings From a Diary Study,'' Translational
Behavioral Medicine, vol. 3, pp. 10-16, 2013.
6. Cokkinides, V., M. Weinstock, D. Lazovich, et al., ``Indoor
Tanning Use Among Adolescents in the United States, 1998-2004,''
Cancer, vol. 115, pp. 190-198, 2009.
7. 78 FR 27117, May 9, 2013.
8. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM205686.pdf.
9. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM383896.pdf.
10. Sivamani, R.K., L.A. Crane, R.P. Dellavalle, et al.,'' The
Benefits and Risks of Ultraviolet Tanning and Its Alternatives: The
Role of Prudent Sun Exposure,'' Dermatologic Clinics, vol. 27, pp.
149-154, 2009.
11. Autier, P. and P. Boyle, ``Artificial Ultraviolet Sources and
Skin Cancers: Rationale for Restricting Access to Sunbed Use Before
18 Years of Age,'' Nature Clinical Practice Oncology, vol. 5(4), pp.
178-179, 2008.
12. National Institutes of Health, Office of Dietary Supplements,
``Dietary Supplement Fact Sheet: Vitamin D'' (https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional).
13. ``IARC Working Group on Artificial Ultraviolet Light (UV) and
Skin Cancer: The Association of Use of Sunbeds With Cutaneous
Malignant Melanoma and Other Skin Cancers: A Systematic Review,''
International Journal of Cancer, vol. 120, pp. 1116-1122, 2006.
14. SEER Stat Fact Sheets: Melanoma of the Skin, https://seer.cancer.gov/statfacts/html/melan.html#incidence-mortality.
15. SEER Cancer Statistics Review 1975-2010, https://seer.cancer.gov/csr/1975_2010/browse_csr.php?sectionSEL=16&pageSEL=sect_16_table.05.html.
16. Gallagher, R.P., J.J. Spinelli, and T.K. Lee, ``Tanning Beds,
Sunlamps, and Risk of Cutaneous Malignant Melanoma,'' Cancer
Epidemiology, Biomarkers & Prevention, vol. 14(3), pp. 562-566,
2005.
17. Boniol, M., P. Autier, P. Boyle, et al., ``Cutaneous Melanoma
Attributable to Sunbed Use: Systematic Review and Meta-Analysis,''
British Medical Journal, vol. 345, p. e4757 July 24, 2012.
18. Dor[eacute], J. and M.C. Chignol, ``Tanning Salons and Skin
Cancer,'' Photochemical & Photobiological Sciences, vol. 11(1), pp.
30-37, 2012.
19. https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CCkQFjAA&url=http%3A%2F%2Ftancanada.org%2Fwp-content%2Fuploads%2F2013%2F05%2Fsuntan_poster_4-final-Montreal.pdf&ei=u8B8U7iiFdbesATr7oGoCA&usg=AFQjCNFNmLHAAiGcthuPeFfKj94zhexEaw&sig2=IZO-wr4jPtD8ql5fvhV7Vg&bvm=bv.67229260,d.cWc&cad=rja.
20. Grant, W.B., ``Critique of the International Agency for Research
on Cancer's Meta-Analyses of the Association of Sunbed Use With Risk
of Cutaneous Malignant Melanoma,'' Dermatoendocrinology, vol. 1(6),
pp. 294-299, 2009.
21. Zhang, M., A.A. Qureshi, A.C. Geller, et al., ``Use of Tanning
Beds and Incidence of Skin Cancer,'' Journal of Clinical Oncology,
vol. 30, pp. 1588-1593, 2012.
22. Mayer, J.A., S.I. Woodruff, D.J. Slymen, et al., ``Adolescents'
Use of Indoor Tanning: A Large-Scale Evaluation of Psychosocial,
Environmental, and Policy-Level Correlates,'' American Journal of
Public Health, vol. 101(5), pp. 930-938, 2011.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Section 878.4635 is revised to read as follows:
Sec. 878.4635 Sunlamp products and ultraviolet lamps intended for use
in sunlamp products.
(a) Identification. A sunlamp product is any device designed to
incorporate one or more ultraviolet (UV) lamps intended for irradiation
of any part of the living human body, by UV radiation with wavelengths
in air between 200 and 400 nanometers, to induce skin tanning. This
definition includes tanning beds and tanning booths. A UV lamp intended
for use in sunlamp products is any lamp that produces UV radiation in
the wavelength interval of 200 to 400 nanometers in air.
(b) Classification. Class II (special controls). The special
controls for sunlamp products and UV lamps intended for use in sunlamp
products are:
(1) Conduct performance testing that demonstrates the following:
(i) Device meets appropriate output performance specifications such
as wavelengths, energy density, and lamp life; and
(ii) Device's safety features, such as timers to limit UV exposure
and alarms, function properly.
(2) Demonstrate that device is mechanically safe to prevent user
injury.
(3) Demonstrate software verification, validation, and hazard
analysis.
(4) Demonstrate that device is biocompatible.
(5) Demonstrate that device is electrically safe and
electromagnetically compatible in its intended use environment.
(6) Labeling--(i) Sunlamp products. (A) The warning statement below
must appear on all sunlamp products and must be placed in a black box.
This statement must be permanently affixed or inscribed on the product
when fully assembled for use so as to be legible and readily accessible
to view by the person who will be exposed to UV radiation immediately
before the use of the product. It shall be of sufficient durability to
remain legible throughout the expected lifetime of the product. It
shall appear on a part or panel displayed prominently under normal
conditions of use so that it is readily accessible to view whether the
tanning bed canopy (or tanning booth door) is
[[Page 31214]]
open or closed when the person who will be exposed approaches the
equipment and the text shall be at least 10 millimeters (height).
Labeling on the device must include the following statement:
------------------------------------------------------------------------
-------------------------------------------------------------------------
Attention: This sunlamp product should not be used on persons under the
age of 18 years.
------------------------------------------------------------------------
(B) Manufacturers shall provide validated instructions on cleaning
and disinfection of sunlamp products between uses in the user
instructions.
(ii) Sunlamp products and UV lamps intended for use in sunlamp
products. Manufacturers of sunlamp products and UV lamps intended for
use in sunlamp products shall provide or cause to be provided in the
user instructions, as well as all consumer-directed catalogs,
specification sheets, descriptive brochures, and Web pages in which
sunlamp products or UV lamps intended for use in sunlamp products are
offered for sale, the following contraindication and warning
statements:
(A) ``Contraindication: This product is contraindicated for use on
persons under the age of 18 years.''
(B) ``Contraindication: This product must not be used if skin
lesions or open wounds are present.''
(C) ``Warning: This product should not be used on individuals who
have had skin cancer or have a family history of skin cancer.''
(D) ``Warning: Persons repeatedly exposed to UV radiation should be
regularly evaluated for skin cancer.''
(c) Performance standard. Sunlamp products and UV lamps intended
for use in sunlamp products are subject to the electronic product
performance standard at Sec. 1040.20 of this chapter.
Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12546 Filed 5-29-14; 11:15 am]
BILLING CODE 4160-01-P
