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Tell the FDA: +/-20% BG meter accuracy is not enough!

Update to post below: Amy Tenderich (Diabetes Mine) has posted a couple updates on this issue, including a white paper released by Roche and an interview with Ellen Ullman, mother to a son with type 1 and the only patient advocate at the FDA’s meeting. The interview is eye-opening around the lack of standards for BG meters, lack of information for consumers, and the industry’s general attitude that the status quo is good enough.


A number of blogs picked up this issue this week – passing it on to spread the word:

On March 16-17, the FDA held a meeting to review whether BG meter accuracy standards should be tightened. Some industry representatives argued against greater accuracy, suggesting that current standards are sufficient. (Sure – we can reduce a1cs without greater accuracy from the meters our management is based on, no problem!)

The FDA is taking comments on this issue until Tuesday, April 20, 2010 by 5:00 PM EST (according to the Federal Register).
To comment: click on the FDA Comments Docket (or go to and search for Docket No. FDA-2009-N-0604).
Flood the FDA with comments – let them know that industry can and needs to do better!

 For more details about the meeting, see Scott Strumello’s blog. Keri Sparling, Kelly Kunik, Bennet (YDMV), and others have good posts on the issue as well.

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