Document ID: FDA-2008-D-0457-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability
Posted Date: 2008-09-19T04:00Z

[Federal Register: September 19, 2008 (Volume 73, Number 183)]
[Notices]               
[Page 54406-54407]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se08-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Clinical Investigations 
of Devices Indicated for the Treatment of Urinary Incontinence.'' This 
draft guidance document describes FDA's proposed recommendations for 
clinical investigations of medical devices indicated for the treatment 
of urinary incontinence. This draft guidance is not final nor is it in 
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by December 18, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Clinical Investigations of Devices 
Indicated for the Treatment of Urinary Incontinence'' to the Division 
of Small Manufacturers, International, and Consumer Assistance (HFZ-
220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850.Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 240-276-3151. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. 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 (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4130.

SUPPLEMENTARY INFORMATION:

I. Background

    Urinary incontinence is defined as the involuntary loss of urine. 
This draft 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 draft guidance 
describes FDA's proposed recommendations for human clinical trials that 
involve the use of any type of urinary incontinence device, including, 
but not limited to, urological clamp for males; nonimplanted, 
peripheral and

[[Page 54407]]

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.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized will represent 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 draft guidance may do 
so by using the Internet. To receive ``Clinical Investigations of 
Devices Indicated for the Treatment of Urinary Incontinence,'' you may 
either send an e-mail request to dsmica@fda.hhs.gov to receive an 
electronic copy of the document or send a fax request to 240-276-3151 
to receive a hard copy. Please use the document number 1636 to identify 
the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft 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 parts 50 and 56 have been approved under OMB control 
number 0910-0130.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: September 2, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-21971 Filed 9-18-08; 8:45 am]

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