[Federal Register Volume 62, Number 112 (Wednesday, June 11, 1997)]
[Proposed Rules]
[Pages 31771-31775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15312]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. 97N-0199]
General and Plastic Surgery Devices: Reclassification of the
Tweezer-Type Epilator
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify the tweezer-type epilator from class III to class I when
intended to remove hair. FDA also proposes to exempt this device from
the premarket notification requirements. This reclassification is being
proposed on the Secretary of Health and Human Services' own initiative
based on new information. This action is being taken under the Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Medical
Device Amendments of 1976 (the 1976 amendments) and the Safe Medical
Devices Act of 1990 (the SMDA).
DATES: Written comments by September 9, 1997. FDA proposes that any
final regulation based on this proposal become effective 30 days after
date of publication in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Stephen P. Rhodes, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authorities
The act, as amended by the 1976 amendments (Pub. L. 94-295) and the
SMDA (Pub. L. 101-629), established a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the act (21 U.S.C. 360c) established three categories (classes) of
devices, depending on the
[[Page 31772]]
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).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the
amendments), 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. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as post amendment devices, are classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until FDA issues an order
finding the device to be substantially equivalent, under section 513(i)
of the act, to a predicate device that does not require premarket
approval. The agency determines whether new devices are substantially
equivalent to previously offered devices by means of premarket
notification procedures in section 510(k) of the act (21 U.S.C. 360(k))
and 21 CFR part 807 of the regulations.
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Reclassification of classified preamendments devices is governed by
section 513(e) of the act. This section provides that FDA may, by
rulemaking, reclassify a device (in a proceeding that parallels the
initial classification proceeding) based upon ``new information.'' The
reclassification can be initiated by FDA or by the petition of an
interested person. The term ``new information,'' as used in section
513(e) of the 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 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).)
Reevaluation of the data previously before the agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of changes in ``medical science.'' (See
Upjohn v. Finch, supra, 422 F.2d at 951.) However, regardless of
whether data before the agency are past or new data, the ``new
information'' on which any reclassification is based is required to
consist of ``valid scientific evidence,'' as defined in section
513(a)(3) of the act and 21 CFR 860.7(c)(2). FDA relies upon ``valid
scientific evidence'' in the classification process to determine the
level of regulation for devices. For the purpose of reclassification,
the valid scientific evidence upon which the agency relies must be
publicly available. Publicly available information excludes trade
secret and/or confidential commercial information, e.g., the contents
of a pending PMA (see section 520(c) of the act (21 U.S.C. 360j(c)).
Section 513(d)(2)(A) of the act authorizes FDA to exempt, by
regulation, a generic type of class I device from, among other things,
the requirement of premarket notification in section 510(k) of the act
after stating the reasons for making such requirement inapplicable.
Such exemption permits manufacturers to introduce into commercial
distribution generic types of devices without first submitting a
premarket notification to FDA. If FDA has concerns about certain types
of changes to a particular class I device, the agency may grant a
limited exemption from premarket notification for that generic device.
In 1990, the SMDA added section 515(i) to the act. This section of
the act requires FDA to issue an order to manufacturers of preamendment
class III devices and substantially equivalent postamendments devices
for which no final regulation requiring the submission of PMA's has
been issued. This order requires such manufacturers to submit to the
agency a summary of, and a citation to, any information known or
otherwise available to them respecting such devices, including adverse
safety and effectiveness information that has not been submitted under
section 519 of the act (21 U.S.C. 360i). Section 519 of the act
requires manufacturers, importers, distributors, and device user
facilities to submit adverse event reports of certain device-related
events and reports of certain corrective actions taken. Section 515(i)
of the act also directs FDA to either revise the classification of the
device into class I or class II or require the device to remain in
class III and establish a schedule for the issuance of a rule requiring
the submission of PMA's for those devices remaining in class III.
In the Federal Register of May 6, 1994 (59 FR 23731), FDA announced
the availability of a document setting forth its strategy for
implementing the provisions of SMDA that require FDA to review the
classification of preamendments class III. Under this plan, the agency
divided preamendment class III devices into the following three groups:
Group 1 devices are devices that FDA believes raise significant
questions of safety and/or effectiveness, but are no longer used or are
in very limited use; Group 2 devices are devices that FDA believes have
a high potential for being reclassified; and Group 3 devices are
devices that FDA believes are currently in commercial distribution and
are not likely candidates for reclassification. FDA also announced its
intention to call for submission of PMA's for the 15 highest priority
devices in Group 3, and for all Group 1 devices. The agency also
announced its intention to issue an order under section 515(i) of the
act for the remaining Group 3 devices and for all Group 2 devices.
In the Federal Register of August 14, 1995 (60 FR 41984 and 41986),
FDA published two orders for certain class III devices requiring the
submission of safety and effectiveness information in accordance with
the Preamendments Class III Strategy document for implementing section
515(i) of the act. The orders describe in detail the format for
submitting the type of information required by section 515(i) of the
act so that the information submitted would clearly support either
reclassification of the device into class I or II or retention of the
device in class III. The orders also scheduled the required submissions
in groups of nine devices at 6-month intervals beginning with August
14, 1996. The devices proposed in this regulation were included in the
August 14, 1995, Docket No. 94N-0417 Order on Group 2 devices.
II. Regulatory History of the Device
In the Federal Register of January 19, 1982 (47 FR 2810), FDA
published a proposed rule to classify the tweezer-type epilator into
class III. The preamble included the classification recommendation of
the General and Plastic Surgery Devices Classification Panel (the
panel). The panel's recommendation included a summary of the reasons
why the device should be subject to premarket approval and identified
certain risks to health
[[Page 31773]]
presented by the device, including: (1) Cataract formation:
Nonionization radiation emitted from the device may cause heating of
the lens of the eye leading to cataract formation (opacity of the lens
of the eye); (2) pacemaker interference: Patients with pacemakers may
experience arrhythmias from the use of the device; and (3) nonionizing
radiation exposure: The 27 megahertz (MHz) electromagnetic radiation
emitted from the tip of the tweezer may be potentially hazardous to
organs other than the eye.
In the Federal Register of June 24, 1988 (53 FR 23856), FDA
published a final rule classifying the tweezer-type epilator into class
III (21 CFR 878.5360).
In the Federal Register of May 6, 1994 (59 FR 23731), FDA
categorized the tweezer-type epilator as a Group 2 device, which FDA
believes has a high potential for being reclassified. The agency also
announced its intent to issue an order under section 515(i) of the act
for Group 2 devices.
In the Federal Register of August 14, 1995 (60 FR 41986), FDA
published an order requiring manufacturers of tweezer-type epilators to
submit safety and effectiveness information in accordance with the
Preamendments Class III Strategy document for implementing section
515(i) of the act. Between August 8, 1996, and September 24, 1996, four
summaries of safety and effectiveness information were submitted to the
agency (Refs. 1 through 4). These summaries recommended that the
tweezer-type epilator be reclassified into class I or class II and
provided information to assist FDA in reclassifying the device.
III. Device Description
FDA is proposing the following device description based on the
agency's review: The tweezer-type epilator is a device intended to
remove hair by destroying the dermal papilla of a hair. The energy
provided at the tip of the tweezer used to remove hair may be radio
frequency, galvanic (direct current), or a combination of radio
frequency and galvanic energy. This new device description reflects the
entire array of energy sources of tweezer-type epilators on the market.
IV. Proposed Reclassification
FDA is proposing that the tweezer-type epilator intended to remove
hair should be reclassified from class III to class I. FDA believes
that class I would provide a reasonable assurance of safety and
effectiveness of the device for its intended use. FDA is also proposing
that the device be exempt from premarket notification requirements.
V. Risks to Health
When the tweezer-type epilator was proposed for classification into
class III in 1982, the panel identified certain risks to health that
they believed use of the device presented. The risks to health
identified were: (1) Cataract formation: Nonionization radiation
emitted from the device may cause heating of the lens of the eye
leading to cataract formation (opacity of the lens of the eye); (2)
pacemaker interference: Patients with pacemakers may experience
arrhythmias from the use of the device; and (3) nonionizing radiation
exposure: The 27 MHz electromagnetic radiation emitted from the tip of
the tweezer may be potentially hazardous (47 FR 2810). No other risks
to health were identified by FDA when the device was classified into
class III in 1988 (53 FR 23856).
One of the 515(i) submissions identified an additional potential
risk to health, burning of the skin, associated with the use of
electronic tweezer-type epilators (Ref. 2). If the tweezers touch the
skin accidentally during the procedure, the skin is instantly burned
and the burned tissue is pulled away on the tip of the tweezer. Another
515(i) submission stated that heat buildup during the use of galvanic
tweezer-type epilators could potentially result in smoking, sizzling,
and even a mild shock (Ref. 3).
VI. Summary of the Reasons for the Reclassification
In accordance with section 513(e) of the act and 21 CFR 860.130,
based on new information with respect to the device, FDA, on its own
initiative, is proposing to reclassify the tweezer-type epilator from
class III to class I when intended to remove hair because general
controls would provide reasonable assurance of safety and
effectiveness. FDA is also proposing to exempt the device from
premarket notification procedures because: (1) There is no history of
significant risks to health; (2) the characteristics of the device
necessary for safety and effectiveness are established; (3) any
anticipated changes that could affect safety and effectiveness of the
device could be readily detected and will not likely result in a change
of classification of the device; and (4) there is no significant
history of false and misleading claims associated with the use of the
device.
Another reason for proposing reclassification of the tweezer-type
epilator into class I is that the needle epilator also intended to
remove hair by destroying the dermal papilla of hair was reclassified
from class II into class I and exempted from premarket notification
procedures in 1996 (61 FR 44013, August 27, 1996). FDA believes
proposing reclassification of the tweezer-type epilator into class I
provides consistency in the classification of the device.
VII. Summary of Data Upon Which the Reclassification is Based
A. Previously Identified Risks to Health
No reports of cataract formation, pacemaker interference, or any
other adverse nonionizing radiation exposure effects associated with
the use of the tweezer-type epilator were found in the literature, in
FDA's voluntary Device Experience Network (DEN) and Mandatory Device
Reporting (MDR) data bases, or in the 515(i) submissions (Refs. 1
through 4).
One of the 515(i) submissions (Ref. 4) did address the possible
risks to health of cataract formation and pacemaker interference. This
submitter had its device tested for radio frequency and microwave
radiation emission. There was no detectable emission from the device in
the 10-300 MHz range. Radio frequency tweezer-type epilators utilize
13.56, 27.12 or 40.68 MHz to remove hair. Thus, the probability of the
use of radio frequency tweezer-type epilators leading to cataract
formation and causing pacemaker interference is low during the proper
use of the device.
B. Burning of the Skin and Electrical Shock
Although one 515(i) submission identified burning of the skin as a
potential risk to health (Ref. 2) and another 515(i) submission
identified electrical shock as another potential risk to health (Ref.
3), no reports of burning of the skin or electrical shock associated
with use of the device were found in the literature or in the agency's
DEN or MDR data bases.
C. Adverse Experience Reports
The DEN data base included some reports of lack of clinical
effectiveness and misleading claims of permanent hair removal
associated with use of the device. There also was one report of pain,
infection, and inadequate directions; one report of scarring; and two
reports of ingrown/infected hairs. There were no reports of these or
any other adverse effects associated with the use of the device found
in the MDR data base. There also were no reports of adverse effects in
the records of the Consumer Product Safety Commission.
Based on the new information submitted to it, and the agency's own
review of the literature and its DEN and MDR data bases, FDA has
concluded
[[Page 31774]]
that the risks to health identified when the device was classified into
class III and the new potential identified risks to health do not
appear to be risks to health when the device is used properly. FDA now
believes that general controls are sufficient to reasonably ensure that
the device is safe and effective for its intended use. FDA also
believes that the device should be exempted from the premarket
notification procedures because agency review of premarket notification
submissions will not increase the safety and effectiveness of the
device.
D. Benefits of the Device
The psychological stress of embarrassingly excessive hair growth is
well documented, and the elimination of unwanted hair through
destruction of the papilla of the hair follicle is fairly well
characterized (Refs. 5 through 9). FDA has concluded from the
literature and its knowledge of the device that the tweezer-type
epilator can remove hair and that the performance parameters of the
device in regards to safety are also well documented and understood.
The device has had a reasonable record of safety for over 20 years of
use.
There is little published information in regards to the claims of
hair removal by tweezer-type epilators and only one published clinical
study (Ref. 8) specifically investigating the use of tweezer-type
epilators. In this study, eight subjects were treated with a tweezer-
type epilator. The same area of skin area on each subject was retreated
with the device 5 to 7 months later and the epilated hairs were
counted. In three of the subjects, fewer hairs were counted, and more
hairs were counted in five subjects. The differences in hair counts
were not significant in any of the subjects.
Two of the 515(i) submissions (Refs. 3 and 4) provided unpublished
clinical information supporting the effectiveness of tweezer-type
epilators for hair removal. Although the numbers of subjects in both
studies are low, these study results are suggestive of clinical
effectiveness. In one study (Ref. 4), 12 subjects with 14 epilation
sites were treated monthly for 6 months with both a radio frequency
tweezer-type epilator and the same tweezer-type epilator with the radio
frequency energy source disabled. Use of the radio frequency disabled
device was considered equivalent to manual plucking. The epilated hairs
were counted at 6 months and at 9 months after 3 months of no
treatment. After 6-month treatment, there were fewer hairs in both
groups (52.3 percent fewer in the radio frequency tweezer-type epilator
group and 19.1 percent fewer in the radio frequency disabled tweezer-
type epilator group). After 3 months of followup with no treatment, the
radio frequency treated group had 46.3 percent fewer hairs indicating
that hair loss persisted 3 months after the last treatment. The radio
frequency disabled tweezer-type epilator group had the same number of
hairs as before treatment indicating there was no overall hair loss
after the last treatment.
In the second unpublished study (Ref. 3), use of a radio frequency
tweezer-type epilator weekly for 4 months was compared to use ``at an
earlier time'' of a galvanic epilator in seven subjects for 9 weeks.
The radio frequency tweezer-type epilator subjects were examined (hair
counts) at 15 and 30 days after the last treatment given at 4 months.
Hair loss was reported to be 79 percent in the radio frequency epilator
group and about 60 percent in the galvanic epilator group. Because the
treatment schedules of the two groups are not identical, it is not
possible to draw a definitive conclusion from this report other than it
is suggestive of sustained hair removal.
Use of the noninvasive tweezer-type epilator eliminates some risks
to health associated with the use of the needle-type epilator. The
needle-type epilator, an invasive device, removes unwanted hair by
inserting a wire needle into the hair follicle to destroy the dermal
papilla of a hair. Serious adverse device events associated with the
use of needle-type epilators are also rare, but they include reports of
temporary pain, edema, erythema, scarring, infection, and posttreatment
hyper- and hypopigmentation; a case of diphtheroid endocarditis; and
spreading of flat warts (Refs. 6 and 9).
FDA now believes, based on publicly available information, that the
tweezer-type epilator can be regulated as a class I device (general
controls) to reasonably assure the device's safety and effectiveness.
FDA further believes that agency review of premarket notification
submissions for the device will not enhance public health.
VIII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday:
1. 515(i) Submission submitted by Burke Associates
International, Inc., received August 8, 1996.
2. 515(i) Submission submitted by Lucy Peters, International,
Ltd., received September 5, 1996.
3. 515(i) Submission submitted by The Helene Edgar Corp.,
received September 10, 1996.
4. 515(i) Submission submitted by Removatron International
Corp., received September 24, 1996.
5. Chernosky, M. E., ``Permanent Removal of Superfluous Hair,''
Texas Medicine, 67:72-78, 1971.
6. Hobbs, E. R., J. L. Ratz, and B. James, ``Electrosurgical
Epilation,'' Dermatologic Clinic, 5:437-444, 1987.
7. McKinstry, C. T., M. Inaba, and J. N. Anthony, ``Epilation by
Electrocoagulation: Facts that Result in Regrowth of Hair,'' Journal
of Dermatologic Surgery and Oncology, 5:407-411, 1979.
8. Verdich, J., ``A Critical Evaluation of a Method for
Treatment of Facial Hypertrichosis in Women,'' Dermatologica,
168:87-89, 1984.
9. Wagner, R. F., Jr., J. M. Tomich, and D. J. Grands,
``Electrolysis and Thermolysis for Permanent Hair Removal,'' Journal
of the American Academy of Dermatology, 12:441-449, 1985.
IX. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(2) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
X. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The agency believes that this proposed rule is consistent with
the regulatory philosophy and principles identified in the Executive
Order. In addition, the proposed rule is not a significant regulatory
action as defined by the Executive Order and so is not subject to
review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Reclassification of this device from class III to
class I will relieve all manufacturers of the device of the cost of
complying with the premarket
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approval requirements in section 515 of the act. Because
reclassification will reduce regulatory costs with respect to this
device, it will impose no significant economic impact on any small
entities, and it may permit small potential competitors to enter the
marketplace by lowering their costs. The Commissioner of Food and Drugs
therefore certifies that this proposed rule, if issued, will not have a
significant economic impact on a substantial number of small entities.
In addition, this proposed rule will not impose costs of $100 million
or more on either the private sector or State, local, and tribal
governments in the aggregate, and therefore a summary statement of
analysis under section 202(a) of the Unfunded Mandates Reform Act of
1995 is not required.
XI. Comments
Interested persons may, on or before September 9, 1997, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 878 be amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c,
360e, 360j, 360l, 371).
2. Section 878.5360 is revised to read as follows:
Sec. 878.5360 Tweezer-type epilator.
(a) Identification. The tweezer-type epilator is a device intended
to remove hair by destroying the dermal papilla of a hair. The energy
provided at the tip of the tweezer used to remove hair may be radio
frequency, galvanic (direct current), or a combination of radio
frequency and galvanic energy.
(b) Classification. Class I (General Controls). The device is
exempt from premarket notification procedures in subpart E of part 807
of this chapter.
Dated: May 30, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-15312 Filed 6-10-97; 8:45 am]
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