Advisory Committees
June 10, 2009: Gastroenterology and Urology Devices Panel Meeting Announcement
| Name of Committee | Gastroenterology and Urology Devices Panel |
| Date and Time | June 10, 2009, 8:00 a.m. - 5:00 p.m. |
| Location | Holiday Inn, Ballroom Two Montgomery Village Ave., Gaithersburg , MD |
| Agenda | The committee will discuss and make recommendations regarding general issues related to the use of ultrafiltration devices in the treatment of extracellular fluid overload in patients experiencing heart failure. Specifically, the committee will address the use of these devices in patients experiencing heart failure in the following terms: identifying the most appropriate heart failure patients for whom these treatments should be indicated; determining where these treatments fit within the spectrum of treatment options; and defining what level of clinical evidence is necessary to adequately evaluate and provide labeling for these devices. |
| Meeting Materials | FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at the Advisory Committee website, click on year 2009 and scroll down to the appropriate advisory committee link. |
| Public Participation Information |
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 29, 2009. |
| Contact Information |
Megan Mickal, Center for Devices and Radiological Health, (HFZ-470) Food and Drug Administration 9200 Corporate Blvd. Rockville, MD 20850 Phone: 240-276-4151
FDA Advisory Committee Information Line 1-800-741-8138 (301-443-0572 in the Washington, DC area) code 3014512523
Please call the Information Line for up-to-date information on this meeting. A notice in the FEDERAL REGISTER about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Paul Tran at (301) 827-7001 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2). |