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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeTechnical Electronic Product Radiation Safety Standards Committee
Date and TimeThe meeting was held on the following dates:
May 22, 2002 8:30 AM - 5:00 PM
LocationHilton Washington DC North/Gaithersburg, Salons A and B
620 Perry Parkway
Gaithersburg , MD
Contact InformationOrhan H. Suleiman, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12399. Please call the Information Line for up-to-date information on this meeting.
AgendaThe committee will hear an informal review of ongoing activities associated with electronic products. Following the overview, FDA will discuss its concern about radiation doses associated with x-ray computed tomography (CT), and its current thinking about amending the U.S. performance standard for x-ray CT imaging procedures. Specifically FDA will address possible requirements for: (1) definition and standardization of CT terminology; (2) display of an index of patient radiation dose that could be automatically recorded within a facility quality assurance program; (3) automatic exposure control through modulation of x-ray tube output according to patient dimensions; and (4) limitation of the x-ray field size to that needed for image formation.

In the afternoon, FDA will discuss proposed amendments to the U.S. performance standard for sunlamp products and certain initiatives of international standards organizations concerning sunlamp products. In the final session, FDA will be considering mandatory standards for x-ray security screening systems; FDA will discuss public health considerations regarding these systems that use ionizing radiation.

Background information on the discussion topics will be posted under the Technical Electronic Products Radiation Safety Standards Committee (TEPRSSC) Docket site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2002 and scroll down to TEPRSSC.)

ProcedureInterested 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 May 10, 2002. Oral presentations from the public will be scheduled between approximately 9:45 a.m. and 10:15 a.m., and between 3:15 p.m. and 4 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 10, 2002, 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.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

ConductFDA 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.
Related Documents
Agenda: Text
Brief Summary: Text
Briefing: Text
Roster: Text
Transcript: CorrectionRich Text Format
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).