Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence.” This draft guidance document describes FDA's proposed recommendations for clinical investigations of medical devices indicated for the treatment of urinary incontinence. This draft guidance is not final nor is it in effect at this time.
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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by December 18, 2008.
Submit written requests for single copies of the draft guidance document entitled “Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence” to the Division of Small Manufacturers,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Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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 This draft guidance is intended to assist device manufacturers who plan to conduct clinical investigations of devices intended to treat urinary incontinence in support of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 The draft guidance describes FDA's proposed recommendations for human clinical trials that involve the use of any type of urinary incontinence device, including, but not limited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 Start Printed Page 54407other 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 email@example.com 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.
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.Start Signature
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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