The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to implanted brain-computer interface (BCI) devices for patients with paralysis or amputation.
The document provides an overview of the applicable regulatory framework and also highlights some important aspects to be considered by medical device manufacturers and other parties involved. It is important to mention that due to the legal nature of the document, it does not introduce new rules or requirements but provides additional clarifications and recommendations on achieving and sustaining compliance with the regulatory requirements set forth by the current legislation. The Agency also emphasizes that an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance.
The current version of the document was issued in May 2021. The particular division of the FDA responsible for medical devices covered by the scope of the present guidance is the Office of Neurological and Physical Medicine Devices (OHT5).
Software constitutes one of the most important components of implanted BCI devices as it coordinates the operations of all other elements, including controllers, processing models, and other components. Thus, the correct operation of the software is vitally important for ensuring the safety and effectiveness of the medical device in general. In terms of the information to be provided by the medical device manufacturer regarding the software used, the document refers to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The aforementioned document describes the scope of information and documentation to be provided by the medical device manufacturer depending on the particular software product in question and risks associated thereto. In this regard, it is important to mention that the regulating authority considers the software used in implanted BCI devices to be a “major” level of concern. If the manufacturer considers it to be of a “moderate” or “minor” level of concern, such a position should be duly justified with references to the potential consequences of the failure of the software to operate as intended.
According to the guidance, the FDA expects the manufacturer to provide a full description of the software/firmware (including programming languages, hardware platforms, operating system and use of Off-the-Shelf software, if applicable) supporting the operation of the subject device following the software guidance, commensurate with the appropriate level of concern. These details should be provided to the regulating authority with regard to both new medical devices intended to be placed on the market and also modifications to existing devices that are already available. It is important to mention that changes to medical devices already approved for marketing and use in the US are subject to special regulations on change control. In the case of early feasibility studies, the responsible person shall provide information about the testing conducted to evaluate the actual performance of the software and its safety.
In general, the information to be provided by the medical device manufacturer should cover how the software impacts operations of the device, the risks associated with the use of the device in question for its intended purpose, and also the appropriate testing conducted to validate its performance. If the software is used to control critical functions and elements of the device, the manufacturer shall conduct a rigorous assessment of hazards associated with potential software failures and introduce controls necessary to ensure the continuous safety and performance of the device.
Additionally, the manufacturer shall consider the provisions of software-specific guidance documents issued by the FDA and dedicated to cybersecurity matters and off-the-shelf software.
The Agency states that the documentation related to the software contained in the medical device should provide sufficient evidence to describe the role of the software included in the device, and performance testing to demonstrate that the software functions as designed.
Another important aspect related to implanted BCI devices is associated with human factors resulting from the particular way the device is used. The specific nature of this type of hazard lies in its ability to appear even if the device itself is fully compliant with the applicable regulatory requirements and operates as intended. Thus, it becomes difficult for the medical device manufacturer to foresee and prevent such cases by implementing technical measures. In most cases, such risks arise due to issues related to the user interface design. In such cases, the user fails to interpret the directions for use provided by the manufacturer correctly. The potential consequences of such incidents could also vary significantly and, in some cases, could result in serious health disorders. Thus, the medical device manufacturer shall take all the steps necessary to identify potential risks associated with the improper use of a medical device and implement the measures to reduce such risks and mitigate potential consequences.
For this purpose, the manufacturer shall analyze the behavior of users and the conditions in which the device will be used. Using this information, the manufacturer will consider use-related risks during the initial design and development of a medical device.
As mentioned, in some cases, implanted BCI devices could be subject to early feasibility studies. Under the general rule, such studies are mostly intended to evaluate the general safety and performance of a medical device itself and to identify potential technical issues. At the same time, the authority encourages medical device manufacturers to pay additional attention to human factors as well. It is stated that an early feasibility study facilitates the collection information necessary to identify potential risks associated with the use of a medical device in a way other than prescribed by the manufacturer. In this regard, the FDA also refers to the guidance dedicated to applying human factors and usability engineering to medical devices. Thus, the assessment of human factors should be initially included in a study protocol. In such case, the information obtained upon completion of a trial could be used by the medical device manufacturer to develop and implement the changes and modifications to the device reasonably necessary to reduce the risk of using the device not as prescribed in the directions for use, as well as the hazards associated thereto.
In summary, the present FDA guidance addresses the most important aspects related to implanted BCI devices. For instance, the document outlines the scope of information to be provided by the medical device manufacturer with regard to the software used to operate the device, as well as describes the way the manufacturer shall identify and mitigate the risks associated with human factors.
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