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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeClinical Chemistry and Clinical Toxicology Devices Panel
Date and TimeThe meeting was held on the following dates:
Oct 29, 2001 8:00 AM - 5:00 PM
LocationHilton DC North - Gaithersburg
Salons A, B, C and D, 620 Perry Parkway
Gaithersburg , MD
Contact InformationVeronica J. Calvin, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1243, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12514. Please call the Information Line for up-to-date information on this meeting.
AgendaThe committee will provide advice and recommendations on the types of data and/or labeling needed in premarket notification (510(k)) submissions for glucose test systems to address problems associated with using blood samples from alternate sites, such as the forearm, upper arm, thigh, calf, or base of the thumb. Background information, including the agenda and questions for the committee, will be available to the public on October 26, 2001, on the Internet at http://www.fda.gov/cdrh/panelmtg.html.
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 October 15, 2001. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 m. and between approximately 3 p.m. and 3:30 p.m. on October 29, 2001. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before October 15, 2001, 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.
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
Briefing: PDF
Briefing: Text
Minutes: Text
Summary: Text
Transcript:Part 1PDF
Transcript:Part 2PDF
Transcript:Part 2PDF
Transcript:Part 3PDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).