The Food and Drugs Administration (FDA) has published guidance on glucose monitoring systems intended to be used in healthcare facilities (point-care-use). The document constitutes a final version of the guidance issued previously by the Agency in November 2018. It is the second guidance on blood glucose monitoring systems issued by the FDA in September – the previous one covers all aspects related to the self-monitoring blood glucose test systems intended for home use.
Regulatory Background
The present FDA guidance is intended to provide medical device manufacturers and other parties involved in operations with medical devices with the additional information regarding the 510(k) premarket notifications for blood glucose monitoring systems (BMSs) intended for prescription point-of-care use. In particular, the document provides the manufacturers with the important details related to the performance studies and other aspects to be considered when preparing a 510(k) submission. The FDA also emphasizes that the self-monitoring test systems intended for over-the-counter (OTC) home use by the laypersons are actually falling outside the scope of the present guidance while being addressed in a separate document published by the Agency earlier in September 2020. The guidance also contains references to the applicable voluntary consensus standards the manufacturers may use to demonstrate compliance of medical devices in question with the applicable safety and performance requirements.
Besides the portable blood glucose meters actively used by non-professional customers (laypersons), there are special devices of this type intended to be used by healthcare professionals in the clinical environment. The Agency mentions that the regulatory approach applied for both categories of devices previously was actually based on common requirements, while nowadays the FDA finds necessary to pay special attention to the distinguishing features these devices have, due to which they should be treated differently from a regulatory standpoint. Among other points, the information to be provided in the course of premarket notification submission should be also different. For this particular purpose, the FDA has already issued two separate guidance documents each addressing a particular type of blood glucose monitoring system.
Blood Glucose Monitoring Systems: Key Risks
According to the information available to the FDA, the main risk related to the blood glucose monitoring systems is associated with the potential transmission of blood pathogens. It becomes especially important in the case of blood glucose meters used in healthcare facilities since they are being used for multiple patients. The risk of transmission increases in case if they are not being cleaned and disinfected properly. To address this risk, the medical device manufacturers shall duly implement special measures and controls intended to assist persons using the device in performing its maintenance in a proper and efficient way.
Another point of concern relates to the accuracy and reliability of testing results. The Agency states that in some cases the devices have not been evaluated properly for the particular population they are being actually used in healthcare facilities. In particular, the main difference of clinical use in comparison to home use is that the blood glucose meters used in healthcare facilities are often used for patients that are actually ill, that creates additional risks related to the further clinical actions taken on the basis of the information provided by the devices.
The Agency states that previously most of the medical devices of the aforementioned type have been initially intended to be used by healthy people while later actually being used to monitor glucose level for the patients with serious disorders. This created a situation when the devices intended for home use were actually used in healthcare facilities, even in case if there has been no proper scientific or clinical evaluation covering such use. Thus, according to the position expressed by the FDA, the medical device used in the points-of-care should be initially intended for such use, and also meet the applicable safety and performance requirements, while its manufacturer shall properly demonstrate compliance with such requirements, including by demonstrating substantial equivalence. The present FDA guidance describes the studies to be conducted by the medical device manufacturers for blood glucose monitoring systems for point-of-care professional use.
Scope of the FDA Guidance on BGMSs
The scope of the present FDA guidance on blood glucose monitoring systems covers those regulated under 21 CFR 862.1345 including the following product codes:
- CGA (glucose oxidase method),
- CFR (hexokinase method),
- LFR (glucose dehydrogenase method).
The Agency also outlines the scope of medical devices falling outside the scope of the guidance, namely:
- Chemistry analyzers and other devices used to screen for and/or to diagnose diabetes,
- Both implanted and external glucose sensors, as well as continuous glucose monitoring systems (CGMs),
- Non-invasive glucose measurement devices,
- Special use of blood glucose test technologies.
CLIA Waiver for Blood Glucose Meters
According to the applicable regulations, the blood glucose meters intended for OTC used are eligible for the CLIA waiver and thus could be placed on the market under the simplified regulatory procedure. The Agency states that most of the blood glucose monitoring systems marketed nowadays, including ones actually used in healthcare facilities, have been placed on the market under the aforementioned exclusion. This situation creates additional risks for patients. In order to mitigate these risks, the FDA finds it necessary to require special clearance for BGMSs intended for prescription point-of-care use. In accordance with the regulatory framework described in the present FDA guidance, the medical device manufacturers would have to apply for both review of the 510(k) premarket submission, and also for the CLIA waiver. It is also important to mention that the information required in the context of the 510(k) premarket submission could be also used to support a CLIA waiver application. The Agency also recommends the medical device manufacturer to contact the authority before commencing the clinical study.
Performance Evaluation for Prescription-Use BGMSs
As it was already mentioned before, the scope of the information to be provided by the medical device manufacturer in case of blood glucose monitoring systems intended for prescription point-of-care use should be actually wider than one required for OTC use blood glucose meters. According to the document, when submitting the 510(k) premarket notification, the medical device manufacturer shall provide the exhaustive information covering the following points:
- Precision Evaluation Study,
- Linearity Evaluation Study,
- Method Comparison/User Evaluation,
- Interference Evaluation,
- Flex Studies,
- Meter Calibration and Quality Control Material.
For each of the categories above, the FDA guidance provides detailed clarifications and recommendations describing the particular way the information should be provided.
Summarizing the information provided here above, the FDA guidance on blood glucose monitoring systems for prescription point-of-care use describes the requirements the aforementioned devices should meet, and also the regulatory procedures to be performed when placing them on the US market, as well as the information to be provided by the medical device manufacturer.
It is important to mention that due to its legal nature, the guidance does not introduce any mandatory requirements all parties involved are obliged to follow. Moreover, the Agency allows using of the approach another than described in the guidance, providing that it would be compliant with the applicable requirements (in this case the medical device manufacturer has to consult with the Agency in advance).
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