The Food and Drug Administration (FDA) has published guidance dedicated to the self-monitoring blood glucose test systems intended for over-the-counter use.
Important Notes
The document represents a final version of the document issued previously in November 2018. The presents FDA guidance also replaces the previous guidance dedicated to the same issue published by the FDA earlier in October 2016.
It is important to mention that due to its legal nature, the FDA guidance does not establish any mandatory rules and requirements the industry representatives shall follow. The Agency states that medical device manufacturers may apply the alternative approach, providing that such an approach complies with the applicable safety and performance requirements. Hence, the FDA guidance describes the current thinking of the Agency regarding the matter and provides medical device manufacturers and other parties involved in operations with medical devices with the additional recommendations to be considered to achieve and sustain compliance with the applicable requirements.
In particular, the recommendations provided by the FDA cover the matters related to the 510(k) premarket notifications for self-monitoring blood glucose test systems (SMBGs) intended to be used directly by the laypersons, which is the over-the-counter (OTC) use, including ones used in accordance with the prescription of a healthcare professional. The scope of the document covers performance studies and preparation of the aforementioned notification submissions. At the same time, the devices intended to be used by healthcare professionals in the appropriate institutions and points of care are actually falling outside the scope of the present FDA guidance – the issues associated with such devices are covered by another guidance issued by the FDA.
Regulatory Background
As it is stated in the FDA guidance, there are a lot of portable glucose meters used directly by the patients at home or in a similar non-clinical environment to measure blood glucose values. Initially, these devices have been regulated in the same way as ones intended to be used by healthcare professionals. At the same time, later it was identified that the environment impacts significantly the functions and features of the devices. In particular, the difference in the intended use population resulted in different design specifications. Thus, glucose tests for home use require another regulatory approach to be applied. For instance, the laypersons using medical devices at home have different skills and knowledge regarding the way the glucose test should be used and its results should be interpreted. The storing conditions in case of out-of-the-counter use could vary dramatically too. All these points should be considered by medical device manufacturers to ensure the use of glucose tests in a safe and efficient manner.
Another important aspect the Agency emphasizes is related to the infections that potentially could be transmitted by glucose tests being shared between different patients without proper cleaning and disinfecting. To reduce such risks, the medical device manufacturers shall implement the measures for effective cleaning of the device after use, and also provide the customers with the detailed instructions describing the way the medical device should be cleaned and disinfected. The disinfecting procedures recommended by the medical device manufacturer should be also properly validated for the particular device type, its intended use, and the use environment (home use).
As it was already mentioned before, the scope of the present FDA guidance covers self-monitoring blood glucose test systems intended to be used at home. Such devices are regulated under 21 CFR 862.1345, Glucose Test Systems with the product code NBW. At the same time, the following devices are actually falling outside the scope of the guidance:
- Glucose monitoring test systems intended to be used in the clinical environment,
- Medical devices intended for screening and diagnosing diabetes,
- Continuous glucose monitoring systems (both implanted and external),
- Glucose measurement devices based on the non-invasive methods,
- Glucose measurement devices intended to be used for neonates.
The scope of the FDA guidance on glucose tests covers the devices intended to use capillary whole blood, providing that such device should not be used in the context of glycemic control procedure or any other professional use purpose. The Agency also warns about the risks of potential transmission of bloodborne pathogens associated with the use of such devices on multiple patients.
The guidance outlines the information to be provided by the medical device manufacturer when submitting a 510(k) premarket notification. As it was already mentioned before, the manufacturers are allowed to apply a different approach to demonstrate substantial equivalence to a similar device already placed on the market (predicate).
Bloodborne Pathogen Transmission Reduction
One of the most important parts of the FDA guidance on glucose test systems is dedicated to the special measures to be implemented to mitigate and reduce the risks associated with the potential transmission of bloodborne pathogens. In accordance with the information available to the Agency, the devices covered by the scope of the guidance could transmit bloodborne pathogens in case if not being properly cleaned and disinfected. Thus, the FDA recommends the medical device manufacturers to implement the following measures related to the design and labeling of the devices:
- The indications for use should clearly state that the device is intended for single patient use (home use, only a single user).
- The design of the device and its external surfaces should allow its easy and effective cleaning and disinfecting.
- An effective disinfection method should be developed by the manufacturer and indicated in the submission and the labeling of the device. As was already mentioned before, the disinfection method should be also validated. The appropriate instructions on disinfection procedures should be clear and understandable for laypersons.
- It is important to warn the users that the device should not be shared.
At the same time, the FDA also emphasizes that any additional measures implemented by the manufacturer to improve the safety of glucose test systems should not impact the effectiveness of these devices and the accuracy and reliability of measurements they provide.
Glucose Test Systems Description
The present FDA guidance on glucose test systems also provides certain recommendations regarding the description of the device to be provided by the manufacturer in the context of the 510(k) premarket notification submission. In particular, the Agency recommends to provide the following information:
- General device description, including the description of its components, performance specifications, explanation of the principles the device is based on, user maintenance needs, special features (e.g. this intended to improve the usability of the devices by users with visual impairments or to reduce the bloodborne pathogen transmission risk).
- Details on the software-controlled features including the information the device displays and user messages, the way the device responses, user prompts, and also the error messages and alerts.
The Agency also mentions that the manufacturer shall indicate the way the user shall respond to the aforementioned messages.
Summarizing the information provided here above, the FDA guidance on glucose test systems covers the most important aspects related to the design and labeling of these devices, as well as the information to be provided by the medical device manufacturer in the context of the 510(k) premarket notification submission.
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