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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.

Contact Person:
 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/