FDA to ISO 15197: Not good enough

Posted by Sten Westgard, MS

Here's an interesting quotation from the recent FDA draft guideline on blood glucose meters:

"Sections A-F below indicate the types of device performance information that you should include in a 510(k) submission for a BGMS device. Although many manufacturers design their BGMS validation studies based on the International Standards Organizations document 15197, FDA believes that the criteria set forth in the ISO 15197 standard do not adequately protect patients using BGMS devices in professional settings, and does not recommend using these criteria for BGMS devices." [emphasis added]

Now, note that there is a difference between the ISO 15197 standard for glucose meters that came out in 2003 and the more recent one from 2013, which has tighter guidelines. Is the FDA saying even the most recent guideline isn't good enough?

You don't see that very often.