Our Blog / the diabetes online community on accuracy

We love a surprise.

gift
Regulatory letters rarely bring exciting gifts.
Is this one?

 

We spotted this warning below in a very recent FDA 510(k) approval for a meter. It is labeling that we have not seen perviously. Could the FDA have a new tool to help us StripSafely?

We do not yet fully understand what it may mean; it surfaced for the first time last week. To our knowledge, the approval has not yet resulted in a device yet being sold. So to be fair, until we learn more, we have redacted the brand name of the meter.

We also feel that the language is potentially more interesting without the brand name.  Does this indicate a new regulatory path the FDA is using to help people with diabetes StripSafely? The specific points listed after “does not provide reliable accuracy readings beyond the following margins of error” are the 2003 ISO standard.

Does the Agency no longer consider them to be insufficiently accurate to dose insulin or calibrate a CGM? That would rock our world, ’cause we don’t.

The following is a direct cut and paste from the FDA’s decision summary but with {Brand} inserted where the brand name appears in the summary. The capitalization is from the FDA summary.

CAUTION

Blood Glucose Meter Accuracy is the most important criteria in determining glucose meter quality. The {Brand} Blood Glucose Monitoring System is less accurate than most other blood glucose meters sold today. The {Brand} meter does not provide reliable accuracy readings beyond the following margins of error:
For glucose concentrations < 75 mg/dL, 95% of the results shall be within ± 15 mg/dL.
For glucose concentrations > 75 mg/dL, 95% of the results shall be within ± 20%.

DO NOT USE THE {Brand} TO CALCULATE INSULIN DOSAGES.

DO NOT USE THE {Brand} TO CALIBRATE CONTINUOUS GLUCOSE MONITORS

Some may ask why approve it at all? Simple. There are rules and FDA plays by them. Legislation created the 510(k) substantially equivalent path. The FDA, very correctly, follows the law. If a device meets the requirements of being “substantially equivalent”, it qualifies for approval.

It appears however that there maybe some flexibility in device labels.

We look forward to learning and sharing more on this it in 2014.

Happy New Year.

Thanks for the surprise gift FDA!

 

* source: http://www.accessdata.fda.gov/cdrh_docs/reviews/K122340.pdf

Bennet Dunlap

5 Comments

  1. Very interesting. I looked up the FDA letter after reading this blog post, and was surprised to find that it said that the text quoted above needs to be included on the paper insert, and the capitalized part on the outside of the test strip box! This is taking a hard-line approach if I ever heard of one!

    As you mentioned, perhaps they can’t stop its release, but they can impose restrictions that will make them want to do better.

    I don’t know if this is a direct result from StripSafely or not, but the campaign may have had some influence. Well-done!

    Reply
  2. Thanks Scott.

    If we had some influence great but the real driver here I am sure is the FDA desire to move to higher standards. We really are preaching to the choir or vis a versa.

    Still we love a nice present with a bow. Hope to know more in January.

    Reply
  3. As a participant on behalf of the manufacturer in the 510k application referenced, I can assure you that the FDA has heard the issues raised by StripSafely and other patient advocates. I am also confident that the FDA has and will always require appropriate standards for consumer safety. Patient Advocates like yourselves, along with professionals, help to focus the issues and clarify expectations.
    The product manufacturers and distributors have also heard the same concerns, and are working to address them. The process takes some time, and results aren’t achieved overnight. The 510k at issue was submitted in early 2012. Throughout the process the FDA raised questions about accuracy, as it should. The manufacturer considered withdrawing the 510k, but chose to propose cautionary statements on all of the labeling, obtain the 510k, but NOT to market the product. Upon receiving notice of clearance, the Company immediately notified the FDA of its decision not to market the product. By doing this, the Company can conduct further R&D to develop a state of the art product, with accuracy and precision performance that you demand and expect, and, if achieved, to resubmit it to the FDA for an amendment to the 510k. The amendment process would likely take substantially less time than that required if the Company had withdrawn its submission. If acceptable accuracy standards are not achieved for this meter and test strip combination, then the Company will not market the product.
    I can assure you that the FDA and the manufacturer have heard your voices and understand your concerns. StripSafely is having an impact, and bringing change for the better.

    Reply

So, what do you think ?