[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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Clinical Investigations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draft guidance document describes FDA's proposed recommendations for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 This draft guidance is not final nor is it in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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Clinical Investigations of Devices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Submit written comments concerning this draft guidance to the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]
BILLING CODE 4160-01-S