[Federal Register Volume 63, Number 206 (Monday, October 26, 1998)]
[Rules and Regulations]
[Pages 57059-57060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28579]
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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: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to reclassify the tweezer-type epilator from class III (premarket
approval) to class I (general controls) when intended to remove hair.
FDA is also exempting this device from the premarket notification
(510(k)) requirements. This action is taken 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), the Safe Medical Devices Act of 1990 (the SMDA), and
the Food and Drug Administration Modernization Act of 1997 (FDAMA).
DATES: This regulation is effective November 25, 1998.
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. Background
In the Federal Register of June 11, 1997 (62 FR 31771), FDA issued
a proposed rule to reclassify the tweezer-type epilator from class III
to class I based on new information respecting such device. FDA also
proposed to exempt the device from premarket notification procedures.
Interested persons were given until September 9, 1997, to comment
on the proposed rule. During the comment period, FDA received 10
comments.
One comment supported the proposed reclassification from class III
to class I without providing any specific reason for endorsing the
proposed reclassification. Nine comments were opposed to the proposed
reclassification.
1. Two comments raised concerns about the device's safety. They
stated that the device could cause burns and scars on the skin if it
was improperly manufactured or used. One of these comments mistakenly
believed that FDA was also proposing that the device be exempt from the
current good manufacturing practices (CGMP's) regulation.
FDA agrees that improper manufacturing and use of the device could
result in burns and scars on the skin. FDA also is clarifying for the
record that the device was not proposed to be exempt from the CGMP's
regulation (21 CFR part 820). FDA, however, believes that these risks
can be controlled by general controls such as the CGMP requirements and
labeling requirements.
2. Eight comments (from professional associations, a professional
magazine, practitioners, a former patient, and a manufacturer) opposed
reclassification because they believe the device is not effective in
permanently removing unwanted hair. Four of these eight comments stated
that there are no published scientific data demonstrating that the
device permanently destroys hair. Three of these comments stated that
hair is a dielectric material, i.e., a nonconductor of electricity so
that it is impossible for electricity to descend through the hair to
the dermal papilla and destroy it. Two of these three comments stated
that there is no evidence that the device destroys the dermal papilla
of hair. Another comment indicated that the effectiveness claims for
the device are anecdotal and that there is much information that the
device is ineffective.
FDA acknowledges that the published literature contains no evidence
of statistically significant data showing that the device is effective
in achieving permanent removal of hair. In the proposed rule, FDA
described the one published study using the device (Ref. 1) that
reported that the difference in the hair counts before and after
treatment was not significant. Also in the proposed rule, the agency
described the results of two unpublished studies (Refs. 2 and 3) and
evaluated these results as being only suggestive of effectiveness in
permanently removing hair. Thus, FDA agrees with the comments that
there is no body of significant information establishing the
effectiveness of the device to permanently remove hair. FDA, however,
still believes that the device can be reclassified into class I,
because claims for the device can be addressed by the misbranding
provision of section 502 of the act (21 U.S.C. 352).
3. Three comments stated that the first sentence of the revised
identification statement that ``the tweezer-type epilator is a device
intended to remove hair by destroying the papilla of a hair'' is
misleading because the phrase ``destroying the papilla of a hair'' is
equivalent to stating the device permanently removes hair. They pointed
out that this phrase is part of the identification statement of another
device intended to remove hair, the needle epilator, 21 CFR 878.5350.
Although there is no universally accepted medical definition of
what constitutes permanent removal of hair, FDA acknowledges that the
phrase ``destroying the papilla of a hair'' is widely accepted by many
to be equivalent to stating the device permanently removes hair. FDA
now believes that the use of this phrase in the device identification
statement was inaccurate, and in this final rule, is removing this
phrase from the device identification.
4. Six comments related to the promotional material for the device.
They stated that this material frequently contains false and misleading
claims, specifically that the device is effective for permanent or
long-term removal of hair. Five of these six comments also stressed
that it is FDA's duty to protect the public from false and misleading
claims regarding a product's effectiveness and that reclassification
into class I could increase the number of such claims.
FDA takes seriously its responsibility to protect the public from
false and misleading claims about a product's effectiveness; however,
false and misleading claims may be controlled by
[[Page 57060]]
a general control, namely the misbranding provision of section 502 of
the act. Additionally, FDA acknowledges that there is no statistically
significant scientific data available at this time to support
promotional claims of permanent or long-term removal of hair through
use of the device.
II. FDA's Conclusion
FDA has concluded based on review of the available information that
use of the tweezer-type epilator removes hair and that use of the
device does not present a potential unreasonable risk to the public
health. FDA has also concluded that general controls would provide
reasonable assurance of the safety and effectiveness of the device, and
therefore, the device should be regulated as a class I device.
On November 21, 1997, the President signed FDAMA into law. Section
206 of FDAMA, in part, added a new section 510(l) to the act (21 U.S.C.
360(l)). Under section 501 of FDAMA, new section 510(l) became
effective on February 19, 1998. New section 510(l) provides that a
class I device is exempt from the premarket notification requirement
under section 510(k) of the act, unless the device is intended for a
use which is of substantial importance in preventing impairment of
human health or it presents a potential unreasonable risk of illness
injury (hereafter ``reserved criteria''). FDA has determined that the
device does not meet the reserved criteria, and, therefore, it is
exempt from the premarket notification requirements.
FDA also notes that 21 CFR 878.9(a), Limitations of exemptions from
section 510(k) of the act, requires manufacturers to submit a premarket
notification for any tweezer-type epilator whose intended use is
different from the intended use of legally marketed tweezer-type
epilators.
III. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this final
rule 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.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
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 final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
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. Because this final rule would reduce a regulatory
burden for all manufacturers of tweezer-type epilators covered by this
rule, the agency certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required.
V. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VI. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD
20852, and may be seen by interested persons between 9 a.m. and 4 p.m.,
Monday through Friday.
1. Verdich, J., ``A Critical Evaluation of a Method for
Treatment of Facial Hypertrichosis in Women,'' Dermatologica,
168:87-89, 1984.
2. 515(i) Submission submitted by the Helen Edgar Corp.,
received September 10, 1996.
3. 515(i) Submission submitted by Removatron International
Corp., received September 24, 1996.
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
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 878.5360 is revised to read as follows:
Sec. 878.5360 Tweezer-type epilator.
(a) Identification. The tweezer-type epilator is an electrical
device intended to remove 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 subject to Sec. 878.9.
Dated: October 8, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-28579 Filed 10-23-98; 8:45 am]
BILLING CODE 4160-01-F