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Question 1 of 10
1. Question
FDA insures that blood glucose strips sold to people with diabetes meet approved accuracy standards.
Correct
False. The FDA reviews test of strips presented by manufacturers before the strips can be marketed but not after. Strips can and do vary after they are marketed. There is no post market review.
Incorrect
False. The FDA reviews test of strips presented by manufacturers before the strips can be marketed but not after. Strips can and do vary after they are marketed. There is no post market review.
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Question 2 of 10
2. Question
What is the current standard for accuracy of test strips in the USA?
Correct
Right! +/- 20%
That is a big variance. Still some strips can’t even do that 95% of the time.
Incorrect
Nope, it is +/- 20%
That is a big variance. Still some strips can’t even do that 95% of the time.
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Question 3 of 10
3. Question
Strip accuracy can be thrown off by by:
Correct
Right. All of the above… and a partridge in a pear tree probably throws off the number too.
Incorrect
You’re almost right. All of those listed can mess up results.
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Question 4 of 10
4. Question
New meters and test strips designed for 2013 ISO standards are accurate to:
Correct
Yeah +/- 15%. To their credit, the FDA wanted tighter. That being said, they can’t get the strips that don’t even make the current +/- 20% spread out of the market? We want to change that.
Incorrect
Nope. We wish. It’s +/- 15%. To their credit, the FDA wanted tighter. That being said, they can’t get the strips that don’t even make the current +/- 20% spread out of the market? We want to change that.
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Question 5 of 10
5. Question
FDA is required to follow ISO standards for meter accuracy in the USA.
Correct
Right you are. Will they? We hope so with your help.
Incorrect
Nope. As Fleetwood Mac says, “You can go your own way.”
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Question 6 of 10
6. Question
FDA’s position on proposed new ISO 2013 standards for meter accuracy was:
Correct
Kinda gave you a hint in an earlier question, huh?
Incorrect
They wanted tighter than +/- 15%. Since they are not bound to ISO, they can require better accuracy. Maybe they need to hear from the public?
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Question 7 of 10
7. Question
The FDA has regulatory processes to insure that test strips in the USA meet their approved accuracy standards.
Correct
False. Right, but what the heck!
Hello FDA inspect what you expect.
Incorrect
You would think so but no. Maybe a little public outcry can help.
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Question 8 of 10
8. Question
There is nothing people with diabetes can do to influence meter accuracy.
Correct
Right! False. We can and should write the FDA and congress to hold our Government accountable.
Incorrect
D’OH! WRONG – We can and should write the FDA and Congress to hold our Government accountable.
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Question 9 of 10
9. Question
Which is true?
Correct
Makes you sick, seriously you can drive a truck through those ranges.
Incorrect
Makes you sick, seriously you can drive a truck through those ranges.
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Question 10 of 10
10. Question
I know who and where to send a letter to the FDA.
Correct
Great. Here are some sample letters and if you need help with the addresses at FDA check here.
Incorrect
No worries. Here are some sample letters and the addresses and who you can send a letter to at FDA