Meetings: Medical Devices Advisory Committee,

[Federal Register: July 31, 1998 (Volume 63, Number 147)]

[Notices]

[Page 40912-40913]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr31jy98-89]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

[[Page 40913]]

Name of Committee: Radiological Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on August 17, 1998, 9 a.m. to 5 p.m., and August 18, 1998, 8 a.m. to 4 p.m.

Location: Corporate Bldg., 9200 Corporate Blvd., conference room 020B, Rockville, MD.

Contact Person: Robert J. Doyle, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1212, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12526. Please call the Information Line for up-to-date information on this meeting.

Agenda: On the morning of August 17, 1998, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an image analysis software tool for interproximal caries detection. On the afternoon of August 17, 1998, the committee will discuss, make recommendations, and vote on a PMA for a trans- spectral impedance scanner for use in detecting breast cancer. On August 18, 1998, the committee will discuss and make recommendations on changes to the existing guidance document on digital mammography devices. Single copies of the guidance document entitled ``Information for Manufacturers Seeking Marketing Clearance of Digital Mammography Systems'' can be obtained by contacting the Division of Small Manufacturers Assistance, 1350 Piccard Dr., Rockville, MD 20851, 1-800- 638-2041 or 301-443-6597 or on the Internet ``http://www.fda.gov/cdrh/ ode/digmammo.html''.

Procedure: 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 August 7, 1998. On August 17, 1998, oral presentations from the public will be scheduled between approximately 9:15 a.m. and 9:45 a.m., 1:15 p.m. and 1:45 p.m., and for an additional 30 minutes near the end of the committee deliberations on each of the two agenda items. On August 18, 1998, oral presentations from the public will be scheduled between approximately 8:15 a.m. and 8:45 a.m., and for an additional 30 minutes near the end of the committee deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 11, 1998, 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.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: July 24, 1998. Michael A. Friedman, Deputy Commissioner for Operations.

[FR Doc. 98-20467Filed7-30-98; 8:45 am]

BILLING CODE 4160-01-F