[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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