Page 38 - Glucose Monitoring Devices

34 CHAPTER 2 Analytical performance of SMBG systems

The process for premarket approval of SMBG devices
In Europe, medical devices such as SMBG meters require a Conformite Europeenne
mark before they can be cleared for market release. As part of the application
process, the BGM manufacturer asserts that their product fulfills established
standards with respect to health protection, safety, and environmental protection.
The ISO created the standard ISO 15197 in 2003 [10] for SMBG systems intended
to be used by people with diabetes for therapy adjustments. This standard included a
requirement for analytical performance evaluation. In 2013 [4], this ISO 15197
standard was revised to require more stringent accuracy criteria. This revision
went into effect in Europe in 2016.
Similarly, in the United States, the FDA oversees the premarket certification
process for medical device clearance, in addition to the postmarketing surveillance
after product clearance. In the premarket certification process for blood glucose
monitoring systems, under section 510(k) of the FD&C Act, a manufacturer must
submit a 510(k) application to FDA at least 90 days before commercially releasing
a new product. During this period, the FDA will determine whether the BGM meets
the criteria for Class II market clearance based on whether the device is substantially
equivalent to a legally marketed (predicate) device. Once determined to be Class II,
the meter is subject to the same requirements as predicate devices. The manufacturer
cannot commercialize the device until this clearance takes place.
As Class II devices, new glucose meters must demonstrate that they comply with
the standards set forth by the FDA for SMBG over-the-counter use. Before 2014, the
FDA also utilized the ISO 15197 2003 standard before introducing their own draft
guidance in 2014 for personal SMBG (over-the-counter) BGMs, which was replaced
by final guidance in 2016. The FDA’s guidance employs more rigorous performance
standards than the ISO 15197 2013 standard being used in Europe. Of note, on
November 30, 2018, the FDA released a new draft of a guidance document for
BGM accuracy in point of care (POC) and SMBG (over-the-counter) devices,
with an open review period for comments until February 28, 2019 [11]. This new
draft did not change the major accuracy thresholds or study expectations. For the
purpose of this chapter, we will reference the 2016 guidelines as the current FDA
guidelines.

Analytical performance according to ISO 15197

When evaluating the analytical performance of an SMBG system for personal use, a
device is assumed to being properly handled by well-trained personnel. The original
2003 version of the ISO 15197 standard evaluated measurement precision and
system accuracy. In 2013, the newer update to the ISO 15197 standard required
that analytical performance be evaluated for no less than three test strip lots, rather
than the previous minimum of one test strip lot. The 2013 update also added an
evaluation of SMBG performance in the presence of potentially interfering endog-
enous (e.g., hematocrit variability) or exogenous (e.g., acetaminophen) substances