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[IP] FDA meeting about MiniMed continuous glucose monitoring system (long)
There is a meeting of FDA Clinical Chemistry Advisory Panel on February
26th to discuss the new MiniMed continuous glucose monitoring system.
Members of the public can attend these meetings. You can also testify
at the meeting (I did this at the advisory meeting for Humalog several years
Full information can be found at the web page:
I've copied the appropriate part of that web page below. If you want to
attend I would check on the location the day before as they can be changed
at very short notice.
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical
Devices Advisory Committee
General Function of the Committee:
To provide advice and recommendations to the agency on FDA regulatory
Date and Time:
The meeting will be held on February 26, 1999, 8 a.m. to 5 p.m.
Gaithersburg Marriott, Salons A, B, C and D, 9751 Washingtonian
Blvd., Gaithersburg, MD.
Sharon K. Lappalainen, 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
The committee will discuss, make recommendations and vote on a premarket
approval application (PMA) for a continuous glucose monitoring system
that is indicated for the continuous recording of interstitial glucose
levels in persons with diabetes mellitus.
On February 26, 1999, from 8:30 a.m. to 5 p.m., the meeting will be 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 February 12,
1999. Oral presentations from the public will be scheduled between
approximately 8:45 a.m. and 9:45 a.m. Near the end of the committee
deliberations, a 30-minute open public session will be conducted for
interested persons to address issues specific to the submission or topic
before the committee. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before February 12, 1999, 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 Deliberations:
On February 26, 1999, from 8 a.m. to 8:30 a.m., the meeting will be
closed to permit discussion and review of trade secret and/or
confidential commercial information (5 U.S.C. 552b(c)(4)) relating to
present and future agency issues. Notice of this meeting is given under
the Federal Advisory Committee Act (5 U.S.C. app. 2).
Insulin-Pumpers website http://www.insulin-pumpers.org/