The FDA has proposed new guidance for blood glucose meters — that is, new accuracy standards that meters and strips will have to meet before the FDA clears them for sale. The FDA, which is the government agency that decides which blood glucose meters and strips can be sold in the US, is currently accepting (and encouraging) public comments on these new guidelines, which they’ll take into consideration before issuing final rules. This is a unique opportunity where the FDA is focused on listening – and we need them to hear us. The current rules for glucose meters date back to 2003. If that is indicative of the frequency of rule-making, it may be another decade before we get another chance to help shape the future of meter accuracy.
Let’s make this count. We only have until May 7th.
The number of comments matters. The more FDA receives from us, the more the needs and concerns of the diabetes community will be heard. Other interests will lobby for their views. We must speak up for our own. Our health — and lives — are at stake.
Commenting is easy and fast. Here’s what you need to do:
- Copy the text in the shaded area below.
- Go here and paste it into the comment box.
- Fill out your information. You’re commenting as an individual so UNCHECK the box that says:
- Click continue.
- Review, check the confirmation box, and submit your comments.
- You even get a receipt to confirm your comments were posted.
Learn more about the docket and draft guidance – it may take more than two minutes, but you’ll end up really smart. Start here.
More details on how to comment are in this step-by-step guide.
Comments on third party strips.
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Dockets Open for Comment:
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (this refers to the meters you’d use at home)
Submit comments for: 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)
Our sample comments — feel free to pick and choose, or write your own:
I find many encouraging ideas in the FDA’s draft guidance. Its tighter accuracy standards (particularly in the hypo range) are a huge step forward. The new emphasis on test strip lot release criteria will lead to better quality control, and the requirement for front-of-package accuracy information will make clear that the quality of blood glucose meters varies – and allow users to make informed choices.
The terms “over-the-counter-use” and “prescription point-of-care” use are confusing. Instead, “for patient personal use” and “for professional in clinic use” would make the distinction clearer.
Insulin is a very dangerous drug, with reports showing insulin to be a leading cause of adverse drug reaction emergency room admissions.* Insulin is dosed based on meter readings. People with diabetes therefore need accurate meters to prevent the adverse insulin reactions that cause ER admissions. Both the patent self-use and the caregiver in-office use meters should have the same mandated level of accuracy at the highest level that is practically and economically feasible. (Dr. David Sacks of NIH suggests the proposed professional standards may not be possible at this time.)#
#Close Concerns. 2014-2-27
Currently there is no program in place to ensure that devices continue to maintain the accuracy for which they were approved. This allows quality to slip over time, and puts patient health at risk. There should be a post-market surveillance program with the ability to remove unqualified meters from the market.
There is a wide discrepancy between manufacturers in the number of Medical Device Reports (MDR) that they file.* This is problematic since, as the FDA has stressed, MDRs are essential for the post-market evaluation of glucose meters; failure to comply with MDR requirements puts patient lives at risk. This guidance should require manufacturers to establish and follow robust MDR policies, similar to the proposed lot release criteria, in order for a meter to be cleared.
* Close Concerns. 2013-5-27
The FDA stated in a December 2013 clearance document that “Blood Glucose Meter Accuracy is the most important criteria in determining glucose meter quality.” It also indicated in that document that the 2003 accuracy standards (which this guidance would replace) may not be sufficient, because it required the meter in question — which met the 2003 requirements — to be sold with the following all-cap warning: “DO NOT USE [the meter] TO CALCULATE INSULIN DOSES. DO NOT USE [it] TO CALIBRATE CONTINUOUS GLUCOSE MONITORS.”* The new guidance should make clear that only devices which meet the new tighter standards — and thus can be used to dose insulin or calibrate continuous monitors — can be cleared by FDA (and be considered DME).
The FDA must also be clear that meters that do not meet the new accuracy requirements should not be considered “durable medical equipment.”
The guidance should explicitly state that the only blood glucose meters that can be considered “durable medical equipment” by payers are those that the FDA determines can be used to “make therapy adjustments” — meaning that they’re accurate enough to calculate insulin doses or to calibrate a CGM. Any meter that does not meet the necessary level of quality (and maintain it post-market) cannot be considered DME, and therefore should not be considered eligible for Medicare/health or private insurance reimbursement as DME for diabetes. (The quoted language comes directly from CMS.)
The proposed labeling requirements should specifically state whether a meter has received FDA clearance to “make therapy adjustments” — a statement that could only be made if the meter and its strips met, and continued to meet, these proposed new accuracy standards. Again, this phrasing would clearly distinguish which meters should be eligible for insurance coverage, since only those that are accurate enough to be used for therapy adjustments should qualify.
The proposed new standards are a positive step, and the diabetes patient community is grateful to FDA for this draft guidance. However, this guidance can only be effective if it includes specific quality and labeling requirements that prevent payers from covering antiquated meters, and meter/test strip manufacturers from dragging their heels. These proposed changes, when combined with a post-market surveillance system and enforcement policy, will help ensure that all people with diabetes are able to safely manage our disease.