[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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