From Richmond, Virginia, USA:
The Cygnus corporation is submitting a pre-market approval for the GlucoWatch non-invasive monitor to the FDA. What is the most effective way for us as diabetics and parents of diabetics to help push the FDA for approval and/or wider study of this and other new devices?
Part of the role of the FDA is to ensure that medical products allowed on the market in the United States are both safe and effective for their intended use. The members of the FDA review panel will examine the data submitted by Cygnus and make their recommendation to approve only if they believe the product meets those objectives.
If you feel strongly about this particular product, you can speak during the FDA review session. You'll need to contact the FDA well in advance of the meeting to get yourself on the agenda.
Note: As of May 29, 1999, there was nothing on the FDA website about the GlucoWatch.
Original posting 2 Jun 1999
Posted to Research: Monitoring
Last Updated: Tuesday April 06, 2010 15:09:03
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