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
|Return to the Top of This Page|
Last Updated: Tuesday April 06, 2010 15:09:04
This Internet site provides information of a general nature and is designed for educational purposes only. If you have any concerns about your own health or the health of your child, you should always consult with a physician or other health care professional.
This site is published by T-1 Today, Inc. (d/b/a Children with Diabetes), a 501c3 not-for-profit organization, which is responsible for its contents. Our mission is to provide education and support to families living with type 1 diabetes.
© Children with Diabetes, Inc. 1995-2018. Comments and Feedback.