US regulators have released two extensive draft guidance documents intended to help the medical device industry with the development of blood glucose devices for both home and prescription use.
Devices used to monitor blood glucose levels are used by millions of Americans with diabetes. While FDA has traditionally not observed a significant regulatory distinction between devices with prescription and non-prescription uses, it now says one is needed in light of the fact that "different use settings create distinct intended use populations with unique characteristics and device design requirements."
Regulators cite the differences in knowledge between a trained medical professional and an untrained layperson. The former is "generally more proficient at performing testing and at running appropriate controls, and they typically have a better understanding of test limitations as compared to laypersons," FDA said. Laypersons, by contrast, are less likely to possess those qualities and may be unable to appropriately use the device or correctly interpret data generated by it.
In addition, devices subject to real-world use conditions may need to be more "robust and reliable" than their more carefully used clinical counterparts.
Consumer Use Devices
In light of these differences, regulators now say somewhat different approaches are needed during the development of each-approaches laid out in two new draft guidance documents on 6 January 2014.
The first guidance, Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, describes the "studies and criteria" regulators say they want to see in a premarket application (PMA) or notification (510(k)).
FDA said one of its primary concerns is the risk of transmitting bloodborne pathogens when using the devices. Pathogens like viral hepatitis can be transmitted if devices are shared without first being disinfected. As a result, FDA recommends that all devices be intended for single patient use, and clearly labeled as such. In addition, devices should be designed such that they can be easily cleaned and disinfected. A preferred method of disinfecting the device should also be generated, validated and further tested to ensure it does not damage the device over time.
The guidance also includes other considerations, such as performance evaluation of the device, device descriptions, lot release criteria, software used, device labeling and all studies that must be conducted in support of a premarket submission.
The second guidance, Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, is conceptually similar to the first guidance, but meaningfully different in parts.
For example, it eliminates the single-patient use requirement found in the Over-the-Counter Use guidance, but still maintains the latter's cleaning requirements.
The Point of Care guidance also specifically recommends against the use of the ISO 15197 standard for use in validating the device, calling it inadequate to protect patients in professional settings.
The specific testing and study requirements contained within each guidance are also markedly different, though the data analysis portions are largely similar. One notable difference: FDA expects point-of-care devices to obtain data on a device's use in neonatal populations. The over-the-counter guidance contains no such provisions.
Comments on both draft guidance documents are due to FDA in 90 days.
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (FR)
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use (FR)