[Federal Register Volume 65, Number 149 (Wednesday, August 2, 2000)]
[Rules and Regulations]
[Pages 47305-47306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19489]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 884
[Docket No. 00P-1282]
Obstetrical and Gynecological Devices; Classification of the
Clitoral Engorgement Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
clitoral engorgement device into class II (special controls). The
special control that will apply is a guidance document entitled:
``Guidance for Industry and FDA Reviewers: Class II Special Controls
Guidance Document for Clitoral Engorgement Devices.'' The agency is
taking this action in response to a petition submitted under the
Federal Food, Drug, and Cosmetic Act (the act) as amended by the
Medical Device Amendments of 1976, the Safe Medical Devices Act of
1990, and the FDA Modernization Act of 1997. The agency is classifying
the clitoral engorgement device into class II (special controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.
DATES: This rule is effective September 1, 2000.
FOR FURTHER INFORMATION CONTACT: Colin M. Pollard, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1180.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the act (21 U.S.C.
360c(f)(1)), devices that were not in commercial distribution before
May 28, 1976, the date of enactment of the Medical Device Amendments of
1976 (the amendments), generally referred to as postamendments devices,
are classified automatically by statute into class III without any FDA
rulemaking process. These devices remain in class III and require
premarket approval, unless and until the device is classified or
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with 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 marketed devices by means of
premarket notification procedures in section 510(k) of the act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.
Section 513(f)(2) of the act provides that any person who submits a
premarket notification under section 510(k) of the act (21 U.S.C.
360(k)) for a device that has not previously been classified may,
within 30 days after receiving an order classifying the device in class
III under section 513(f)(1) of the act, request FDA to classify the
device under the criteria set forth in section 513(a)(1) of the act.
FDA shall, within 60 days of receiving such a request, classify the
device by written order. This classification shall be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing such classification.
In accordance with section 513(f)(1) of the act, FDA issued an
order on April 25, 2000, classifying the Urometrics EROS-Clitoral
Therapy Device into class III because it was not substantially
equivalent to a device that was introduced or delivered for
introduction into interstate commerce for commercial distribution
before May 28, 1976, or to a device that was subsequently reclassified
into class I or class II. On April 27, 2000, FDA filed a petition
submitted by Urometrics, requesting classification of the Urometrics
EROS-Clitoral Therapy Device into class II under section 513(f)(2) of
the act.
After review of the information submitted in the petition, FDA
determined that the Urometrics EROS-Clitoral Therapy Device can be
classified in class II with the establishment of special controls. This
device is indicated for use in women with female sexual arousal
disorder, which can present with symptoms of diminished vaginal
lubrication, diminished clitoral and genital engorgement, lowered
sexual satisfaction, and a reduced ability to achieve orgasm. FDA
believes that class II special controls, in addition to the general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
FDA has identified the following risks to health associated
specifically with this type of device: Unknown effects of extended use,
and improper use of the device due to misplacement, or use of the
device over compromised tissue. In addition to the general controls of
the act, this type device is subject to the following special control:
A special controls guidance document entitled ``Guidance for Industry
and FDA Reviewers: Class II Special Controls Guidance for Clitoral
Engorgement Devices.''
Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements under section
510(k) of the act, if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of this type of device and, therefore, the device is
not exempt from premarket notification requirements. FDA review of key
design features, data sets from
[[Page 47306]]
bench studies and clinical trials, other relevant performance data, and
labeling will ensure that minimum levels of performance, for both
safety and effectiveness, are addressed before marketing clearance.
Thus, persons who intend to market this device must submit to FDA a
premarket notification submission containing information on the
clitoral engorgement device before marketing the device.
On April 28, 2000, FDA issued an order to the petitioner
classifying Urometrics EROS-Clitoral Therapy Device and substantially
equivalent devices of this generic type into class II under the generic
name, clitoral engorgement device. FDA identifies this generic type of
device as a device designed to apply a vacuum to the clitoris. It is
intended for use in the treatment of female sexual arousal disorder.
FDA is codifying this device by adding 21 CFR 884.5970. This order also
identifies the following special control applicable to this device: A
special controls guidance document entitled ``Guidance for Industry and
FDA Reviewers: Class II Special Controls Guidance for Clitoral
Engorgement Devices.''
II. Environmental Impact
The agency has determined under 21 CFR 25.34(b) 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.
III. 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) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of
1995 (Public Law 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 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 it 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. FDA knows of only one manufacturer of this type of
device. Classification of these devices from class III to class II will
relieve this manufacturer of the device of the cost of complying with
the premarket approval requirements of section 515 of the act (21
U.S.C. 360e) and may permit small potential competitors to enter the
marketplace by lowering their costs. The agency, therefore, certifies
that the final rule will not have a significant impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement of anticipated costs and
benefits before proposing any rule that may result in an expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million in any one year (adjusted annually for
inflation). The Unfunded Mandates Reform Act does not require FDA to
prepare a statement of costs and benefits for the final rule, because
the final rule is not expected to result in any 1-year expenditure that
would exceed $100 million.
IV. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the order and, consequently, a federalism
summary impact statement is not 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.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
884 is amended as follows:
List of Subjects in 21 CFR Part 884
Medical devices.
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
1. The authority citation for 21 CFR part 884 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 884.5970 is added to subpart F to read as follows:
Sec. 884.5970 Clitoral engorgement device.
(a) Identification. A clitoral engorgement device is designed to
apply a vacuum to the clitoris. It is intended for use in the treatment
of female sexual arousal disorder.
(b) Classification. Class II (special controls). The special
control is a guidance document entitled: ``Guidance for Industry and
FDA Reviewers: Class II Special Controls Guidance Document for Clitoral
Engorgement Devices.''
Dated: July 17, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-19489 Filed 8-1-00; 8:45 am]
BILLING CODE 4160-01-F