[Federal Register Volume 65, Number 97 (Thursday, May 18, 2000)]
[Rules and Regulations]
[Pages 31454-31456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 99N-1309]


Obstetrical and Gynecological Devices; Classification of Female 
Condoms

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
preamendments female condom intended for contraceptive and prophylactic 
purposes. Under this rule, the preamendments female condom is being 
classified into class III (premarket approval). 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 Safe Medical 
Devices Act of 1990, and the FDA Modernization Act of 1997.

DATES: This rule is effective June 19, 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 a proposal published in the Federal Register of June 10, 1999 
(64 FR 31164)

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(hereinafter referred to as the June 10, 1999, proposal), FDA solicited 
comments regarding the proposed classification of female condoms. The 
June 10, 1999, proposal provided the regulatory history of female 
condoms, as well as the recommendation of the Obstetrical and 
Gynecological Device Classification Panel (the Panel) that this 
particular device be classified into class III. Specifically, the Panel 
recommended that this device be classified into class III because no 
published laboratory or clinical study data could be found that 
demonstrate its safety and effectiveness. Also, the Panel believed that 
general controls and special controls would not provide reasonable 
assurance of the safety and effectiveness of the device and the device 
is purported or represented to be for a use in supporting or sustaining 
human life or for a use which is of substantial importance in 
preventing impairment of human health, or presents a potential 
unreasonable risk of illness or injury. FDA agreed with the Panel's 
recommended classification.
    The Panel also recommended that the device be identified as an 
intravaginal pouch because it is a sheath-like device that lines the 
vaginal wall and is inserted into the vagina prior to the initiation of 
coitus. FDA proposed to change the name of the generic type of the 
device to female condom.
    The 90-day comment period ended September 8, 1999, and FDA stated 
that upon consideration of public comment it would issue a final rule 
classifying this device. FDA received one comment endorsing the June 
10, 1999, proposal.

II. Conclusion

    FDA has concluded that the female condom be classified into class 
III because general controls and special controls do not provide 
reasonable assurance of the safety and effectiveness of the device, and 
the device is purported or represented to be for a use in supporting or 
sustaining human life or for a use which is of substantial importance 
in preventing impairment of human health, or presents a potential 
unreasonable risk of illness or injury. FDA has further concluded that 
the generic type of this device be identified as ``female condom.'' FDA 
intends to issue a call for premarket approval applications (PMA's) for 
these devices.

III. 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the rule under Executive Order 
12866, Executive Order 13132, 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.
    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.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. FDA believes that there is no interest at this time 
in marketing the device to be classified by this rule. FDA is taking 
this action because it has determined that premarket approval is 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device, if there is any interest in marketing one 
in the future. Without this rule (and a subsequent requirement for 
PMA's), a person could market a device by claiming substantial 
equivalence to the Gee Bee Ring. All premarket submissions for ``female 
condom'' type devices that FDA has received to date have been for 
devices that have been found to be not substantially equivalent to the 
Gee Bee Ring and, therefore, those devices are not preamendments 
devices and are not to be classified by this rule. Under section 
501(f)(2)(B) of the act (21 U.S.C. 351(f)(2)(B)), a rule requiring 
PMA's for this device could not take effect any sooner than 30 months 
after the effective date of a final rule classifying the device or 90 
days after publication of the final rule requiring the PMA's, whichever 
is later.
    The agency therefore certifies that this rule will not have a 
significant economic impact on a substantial number of small entities. 
In addition, this 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 or analysis under 
section 202(a) of the Unfunded Mandates Reform Act of 1995 is not 
required.

V. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this rule requires no collection of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 884

    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 884 is amended as follows:

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 884.5330 is added to subpart F to read as follows:


Sec. 884.5330  Female condom.

    (a) Identification. A female condom is a sheath-like device that 
lines the vaginal wall and is inserted into the vagina prior to the 
initiation of coitus. It is indicated for contraceptive and 
prophylactic (preventing the transmission of sexually transmitted 
diseases) purposes.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. No 
effective date has been established of the requirement for premarket 
approval for the devices described in paragraph (b) of this section. 
See Sec. 884.3 for effective

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dates of requirement for premarket approval.

    Dated: May 9, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-12526 Filed 5-17-00; 8:45 am]
BILLING CODE 4160-01-F