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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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.

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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 Start Printed Page 12743device, 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 dsmica@fda.hhs.gov 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.

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