[Federal Register Volume 67, Number 115 (Friday, June 14, 2002)]
[Rules and Regulations]
[Pages 40848-40849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15042]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 99N-0922]


Obstetric and Gynecology Devices; Effective Date of Requirement 
for Premarket Approval for Glans Sheath Devices

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 require the filing of a premarket approval application (PMA) or a 
notice of completion of product development protocol (PDP) for glans 
sheath medical devices. The agency has previously published its 
findings regarding the degree of risk of illness or injury designed to 
be eliminated or reduced by requiring the devices to meet the statute's 
approval requirements and the benefits to the public from the use of 
the devices.

DATES: This rule is effective June 14, 2002.

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

    Section 513 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360c) requires the classification of medical devices into 
one of three regulatory classes: Class I (general controls), class II 
(special controls), and class III (premarket approval). In the Federal 
Register of December 29, 1994 (59 FR 67185), FDA issued a final rule 
classifying glans sheath devices into class III. Section 515(b)(1) of 
the act (21 U.S.C. 360e(b)(1)) establishes the requirement that the 
Secretary of Health and Human Services issue a regulation subjecting a 
preamendments device that FDA has classified into class III to 
premarket approval.
    In the Federal Register of May 10, 1999 (64 FR 24967), FDA issued a 
proposed rule to require the filing of a PMA or a notice of completion 
of a PDP for glans sheath devices. In accordance with section 
515(b)(2)(A) of the act, FDA included in the preamble to the proposed 
rule the agency's proposed findings regarding the degree of risk of 
illness or injury intended to be eliminated or reduced by requiring the 
device to meet the statute's approval requirements as well as the 
benefits to the public from use of the device.
    The May 10, 1999, proposed rule also provided an opportunity for 
interested persons to submit comments on the proposed rule and the 
agency's proposed findings. In accordance with section 515(b)(2)(A) of 
the act, FDA also provided an opportunity for interested persons to 
request a change in the classification of the device based on new 
information relevant to its classification. Any petition requesting a 
change in the classification of the devices was required to be 
submitted by May 26, 1999. The comment period closed August 9, 1999.
    FDA received no petitions requesting a change in the classification 
of glans sheath devices. FDA received no comments on the proposed rule.

II. Findings With Respect to Risks and Benefits

    Under section 515(b)(3) of the act, FDA is adopting the findings as 
published in the proposed rule of May 10, 1999. As required by section 
515(b) of the act, FDA published its findings regarding: (1) The degree 
of risk of illness or injury designed to be eliminated or reduced by 
requiring that these devices have an approved PMA or a declared 
completed PDP, and (2) the benefits to the public from the use of the 
device.
    These findings are based on the reports and recommendations of the 
Obstetrics and Gynecology Devices Panel, an FDA advisory committee for 
the classification of the devices as referenced in the May 10, 1999, 
proposed rule.

III. The Final Rule

    Under section 515(b)(3) of the act, FDA adopts the findings as 
published in the preamble to the proposed rule and issues this final 
rule to require premarket approval of glans sheath devices. This final 
rule revises part 884 (21 CFR part 884).
    Under the final rule, a PMA or a notice of completion of a PDP is 
required to be filed on or before September 12, 2002, for any glans 
sheath device that was in commercial distribution before May 28, 1976, 
or that has been found by FDA to be substantially equivalent to such a 
device on or before September 12, 2002. If a PMA or notice of 
completion of a PDP is filed for such devices within this time limit, 
the applicant will be permitted to continue marketing its glans sheath 
device during FDA's review of its submission. Any other glans sheath 
device that was not in commercial distribution before May 28, 1976, is 
required to have an approved PMA or a declared completed PDP in effect 
before it may be marketed.
    If a PMA or a notice of completion of a PDP for a glans sheath 
device is not filed on or before September 12, 2002, that device is 
deemed adulterated under section 501(f)(1)(A) of the act (21 U.S.C. 
351(f)(1)(A)), and commercial distribution of the device must cease 
immediately. The device may, however, be distributed for 
investigational use, if the requirements of the investigational device 
exemption (IDE) regulations (part 812 (21 CFR part 812)) are met. 
Because the intended use of a glans sheath device is contraception, FDA 
considers it to be a significant risk device as defined in the IDE 
regulations (Sec. 812.3(m)(4)).
    As of September 12, 2002, the exemptions in Sec. 812.2(c)(1) and 
(c)(2) from the requirements of the IDE regulations for preamendments 
class III devices cease to apply to any glans sheath device that is: 
(1) Not legally on the market on or before September 12, 2002; or (2) 
legally on the market by September 12, 2002, but for which a PMA or 
notice of completion of a PDP is not filed by September 12, 2002, or 
for which PMA approval has been denied or withdrawn. FDA cautions that 
manufacturers who are not immediately planning to submit a PMA or 
notice of completion of a PDP should submit IDE applications to FDA by 
August 13, 2002, to minimize the possibility of interrupting shipment 
of the device. At this time, FDA is not aware of any firm that is 
marketing this device.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

V. 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), 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,

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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.
    If a rule has a significant economic impact on a substantial number 
of small entities, the Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would minimize any significant impact 
of a rule on small entities. FDA has reviewed the situation and 
believes that no PMAs will be submitted under this final rule. FDA is 
not aware of any marketing of these devices at present. FDA has not 
received any premarket submissions for glans sheath devices in more 
than 15 years. Consequently, 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.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4) 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 adjusted for 
inflation.

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA). The burden hours 
required for Sec. 884.5320(c), included in the collection entitled 
``Premarket Approval of Medical Devices--21 CFR Part 814,'' (64 FR 
4112, January 27, 1999) are reported and approved under OMB control 
number 0910-0231. Therefore, clearance by OMB under the PRA is not 
required.

VII. 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 Executive order and, consequently, a 
federalism summary impact statement 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 884.5320 is amended by revising paragraph (c) to read as 
follows:


Sec. 884.5320  Glans sheath.

* * * * *
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA 
or a notice of completion of a PDP is required to be filed with the 
Food and Drug Administration on or before September 12, 2002, for any 
glans sheath that was in commercial distribution before May 28, 1976, 
or that has, on or before September 12, 2002, been found to be 
substantially equivalent to a glans sheath that was in commercial 
distribution before May 28, 1976. Any other glans sheath shall have an 
approved PMA or declared completed PDP in effect before being placed in 
commercial distribution.

    Dated: May 14, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-15042 Filed 6-13-02; 8:45 am]
BILLING CODE 4160-01-S