[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Notices]
[Pages 12742-12743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0457]


Guidance for Industry and Food and Drug Administration Staff; 
Clinical Investigations of Devices Indicated for the Treatment of 
Urinary Incontinence; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Clinical Investigations of 
Devices Indicated for the Treatment of Urinary Incontinence.'' This 
guidance document describes FDA's recommendations for clinical 
investigations of medical devices indicated for the treatment of 
urinary incontinence.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Clinical Investigations of Devices Indicated for 
the Treatment of Urinary Incontinence '' to the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. G210, Silver Spring, MD 20993-0002, 301-796-6549.

SUPPLEMENTARY INFORMATION:

I. Background

    Urinary incontinence is defined as the involuntary loss of urine. 
This guidance is intended to assist device manufacturers who plan to 
conduct clinical investigations of devices intended to treat urinary 
incontinence in support of premarket approval (PMA) applications or 
premarket notification (510(k)) submissions. The guidance describes 
FDA's recommendations for human clinical trials that involve the use of 
any type of urinary incontinence

[[Page 12743]]

device, including, but not limited to, implanted electrical urinary 
continence devices; implanted mechanical/hydraulic urinary continence 
devices; urological clamp for males; nonimplanted, peripheral and other 
electrical continence devices; protective garment for incontinence; 
surgical mesh; electrosurgical cutting and coagulation device and 
accessories; perineometer; gynecologic laparoscope and accessories; and 
vaginal pessary.
    In the Federal Register of September 19, 2008 (73 FR 54406), FDA 
announced the availability of the draft guidance. Comments on the draft 
guidance were due by December 18, 2008. Two comments were received with 
each comment making multiple recommendations on changes to the content 
of the guidance document.
    The comments included recommended changes to or removals of 
primary, secondary, and composite endpoints and changes to the 
recommended clinical study design. In response to these comments, FDA 
has clarified the appropriate context for recommended endpoints and a 
sponsor's options with respect to use of a given endpoint. FDA also 
revised the recommended requirements for use of voiding diaries and 
clarified the recommendation regarding the randomization of subjects.
    Comments also involved recommendations on the categorization of 
adverse events. In response to these comments, FDA clarified the 
recommendation for categorization of adverse events as either device- 
or procedure-related.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on clinical investigations of devices 
intended to treat urinary incontinence. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Clinical Investigations of Devices Indicated for the Treatment of 
Urinary Incontinence,'' you may either send an e-mail request to 
[email protected] to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1636 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814 have been 
approved under OMB control number 0910-0231; and the collections of 
information in 21 CFR parts 50.23 and 56.115 have been approved under 
OMB control number 0910-0130.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5148 Filed 3-7-11; 8:45 am]
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