Extra Time, Use it Wisely - Meter Accuracy

More Time!

FDA has extended the comment period for glucose system guidance to May 7.

If you have commented, Thank You!

If you have not, join the hundreds of people who have.

  • Need more accurate systems? Say so.
  • Want less accurate phased out? Say so.
  • Should only more accurate systems be approved to dose insulin? Say so.
  • Want enforcement of accuracy? Say so.
Need help? Use our step-by-step guide.

Every "Say so" matters.

Please share the call for comments through your favorite social media sites!

Commented the other day when you posted in DA. :slight_smile:

Thanks for asking nc929:

Click any of the red "Say so" to go to this page:

It links this docket:
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (this refers to the meters you’d use at home)


Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use (this refers to the meters healthcare providers use at the office or in the hospital)


Full how to comment instructions are also linked off the StripSafely page but here is a link to save time:


More about the guidance here:


Sample comments you can use or build from here:


Thank you for posting this information! I'm sure that you are busy with this, and sorry to bother you. I've read through the FDA's Self Monitoring Blood Glucose Test Systems for Over-the-Counter Use Draft Guidance. I want to comment, in specifics, to the FDA. I don't see where in the document it refers to tighter standards for meter accuracy (the +/-15%). Can you point me to the right area?

Thank you again for alerting people about this!


Great question!

There are two different dockets. On for home use. One for in hospital and other clinical use.

There are links here to lots of detail http://www.stripsafely.com/sample-page/guidance/about-guidance/

Both guidance files are
Linked here http://www.stripsafely.com/sample-page/guidance/

The in clinic proposal is 10%. Some well informed science types suggest that may not be possible/ economically feasible.

Worry for being a little cryptic trying to reply with my phone.

Thanks so much for your reply! And especially from your phone!

I already spent time reading the whole document about over the counter meters and strips, and didn't find the specific reference to greater meter accuracy. I'd really like to respond specifically to the FDA--and to be sure I am speaking accurately.

There's not a rush to reply to me, we still have several days. But if you do get a chance to reply about this specific topic in relation to the draft guidelines, I would be very grateful!

Thank you again,


I would be very worried that any increased accuracy requirements might translate into incresased prices for test strips. Already a lot of diabetics have trouble justifying costs of a couple tests a day.

It's important to me that I have strips for testing when I wake up, before I eat, before I drive, before exercise, before I go to bed, etc. I am not too worried about the difference between 90 and 100, but I do need to know if my bg is 40 or 90 or 190 before I drive the car or head out for exercise.

Anything we can do that would encourage competition and drive prices down, I'm all for! There probably is a market (accounting types) who care if their bg is 100 or 110. But I'm mostly looking to differentiate 40 from 80 from 120 from 180 from 240. Note those line up with the sticker on the side of the chemstrip bottle!


Done - Comment tracking #1jy-8bqj-8q0u.

Thank you for all you do!

Your welcome.

Excellent to have you join the team thanks for commenting. Each comment strengthens FDA to support patient views.

How about we unleash black helicopters and price controls on test strip manufacturers, oh wait, did I just say that?

Price and performance in vacuums are a problem. Accurate but too costly, as you point out, serves nobody. Inexpensive but imprecise is not only cheap but dangerous.

I think Tim is spot on hi-lighting the hypo range but 40 to 80 is a tad on the wide side. People should not be on the verge of passing out and or fine. 40 is a loss of cognitive function 80 is a functioning pancreas.

An in inaccurate strip is not worth a penny or a dollar.

The problem is a penny strip is wonderful only if it can tell the difference between 40 and 80.

Thanks for jumping in and making me tnink.

… Wait do I hear rotar blades…?