|
|
| Name of Committee | Obstetrics and Gynecology Devices Panel |
| Date and Time | The meeting was held on the following dates:
Oct 25, 04 10:00 AM - 4:00 PM
|
| Location | Hilton Washington DC/North Gaithersburg, Salons A and B,
Gaithersburg
, MD |
| Contact Information | Michael Bailey, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180 or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512524. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | The committee will discuss and make recommendations on the type of pivotal study needed to support a premarket approval application for fetal monitors that use neural networks for risk assessment. Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the October 25 meeting will be posted on October 22, 2004. |
| Procedure | On October 25, 2004, from 11 a.m. to 4 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by October 18, 2004. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal presentations should notify the contact person before October 18, 2004, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. |
| Closed Committee Information | On October 25, 2004, from 10 a.m. to 11 a.m., the meeting will be closed to the public to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)) regarding pending and future device issues. |
| | Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. |
| Conduct | FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ 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). |
|
