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FDA Panel to Review Alternate Site Blood Glucose Monitoring

The Clinical Chemistry and Clinical Toxicology Panel of the Food and Drug Administration will hold a meeting this week to address concerns associated with blood glucose measurement using alternate site testing. The meeting will be held at the Gaithersburg Hilton in Gaithersburg, Maryland, on Monday, October 29, 2001, from 8:30 a.m. to 5:00 p.m.

The 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.

CWD parents have submitted over 50 emails and letters to the Panel in support of alternate site testing. Laura Billetdeaux, CWD Events Coordinator, and her 11 year old son, Sam, will speak to the panel on behalf of the CWD families who use alternate site testing.

Background information, including the agenda and questions for the committee, can be found at Clinical Chemistry and Clinical Toxicology Devices Panel. Also see CDRH Background Package.

The public is invited to attend.

Stay tuned for a follow up report.

Posted October 28, 2001

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