FDA publishes draft guidance updating SMBG and point-of-care BGM accuracy and study requirements – January 9, 2014

On January 7, the FDA published two guidance documents related to glucose meters, one for SMBG devices (i.e., home use setting) and one for point-of-care devices (i.e., healthcare facilities). FDA sees these use cases as very distinct (we agree!) and has thus published two different guidances. As seen in the table below, both standards are tighter than the updated ISO and CLSI standards, especially in the hypoglycemia range. FDA representatives long maintained that they wanted to improve hypoglycemia accuracy, so it was really terrific to see this actually incorporated into the draft guidance. The draft guidance documents have specific sections devoted to reducing the risk of bloodborne pathogen transmission (this has been an increasing focus of FDA and CDC); performance evaluation and criteria; test strip lot release criteria; software; labeling; and an appendix. The FDA is holding a conference call on Tuesday, January 14 at 3 PM EST (888-354-3866; passcode: BGM) to discuss the guidance documents with the public and offer an opportunity to ask questions. Comments can be submitted for the next 88 days at http://www.regulations.gov.

Regarding the SMBG guidance, we’re glad to see that the FDA’s approach seems much easier to read and understand relative to the new ISO standard (which mixes percentage, absolute numbers in mg/dl, and an error grid – yikes!). Broadly speaking, we believe the guidance is what industry will have expected, and most major companies will likely be well adjusted to these new requirements. The tighter accuracy requirements clearly make the entry barrier higher for low-cost players trying to enter the arena. The big issue is ongoing, as quality control over time is where accuracy can really fall flat, especially for low cost providers. With that in mind, we look forward to updates on the Diabetes Technology Society’s BGM Surveillance Program (as of the last update, a steering committee was being organized to hammer out details).

We are also glad to see the tighter accuracy, since the ripple effect is it will likely improve all CGM accuracy over time. We've heard that some Medicare patients paying for their own CGMs are using cheaper off-shore meters for calibration. In our view, moving better BGM accuracy forward will hopefully improve MARDs to what they really should be, especially for these patients using less accurate meters for calibration. Second, this guidance should also impact the world of artificial pancreas for the same reason - better accuracy for CGM, and thus, more accurate automated insulin delivery. 

A focus of both documents is control of bloodborne pathogen transmission, which is discussed in the introduction and has its own section. We certainly support infection control, though would note that few patients will disinfect their meters in the real-life use setting. This issue is critical in the healthcare setting, as sometimes a patient’s own meter is used, and in others cases it is a shared meter. In that scenario, there is certainly a chance for infection, and we are thus not surprised to see this in the guidance.

--by Adam Brown and Kelly Close