[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