The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published guidance dedicated to the non-clinical testing and clinical considerations of implanted brain-computer interface devices.
The present document constitutes a final version of the guidance initially issued by the FDA in February 2019. Due to the legal nature of the document, its provisions are not binding, and the medical device manufacturers and other parties involved are allowed to apply an alternative approach, providing such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance. In particular, the guidance is intended to provide additional clarifications and recommendations on the matter. In the case of any discrepancies with the provisions of current legislation, the latter should prevail.
Regulatory Background
The scope of the guidance covers Q-Submissions and Investigational Device Exemptions (IDEs) in the context of implanted Brain-Computer Interface (BCI) devices, which are widely used nowadays for certain categories of patients in order to facilitate interactions with their environment. The Agency states that BCI devices covered by the scope of the guidance are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation.
The purpose of the present FDA guidance is to provide additional recommendations to be considered by all the parties involved and assist them in achieving and sustaining compliance with the applicable regulatory requirements. Initially, the discussion on BCI devices was commenced by the Agency earlier in November 2014, when a public workshop took place. The feedback and suggestions collected from the industry representatives during the workshop have been taken into account when developing the present guidance.
In particular, the document contains recommendations for non-clinical testing and clinical study design in the context of implanted BCI devices. The first element, non-clinical testing, is intended to demonstrate that all identified risks associated with the device in question have been properly mitigated before commencing a clinical study. The second element, a clinical study, involves collecting evidence of the safety and effectiveness of the medical device in question to be submitted to the authority with the application itself. The Agency states that non-clinical testing on its own is not sufficient to generate the evidence necessary to demonstrate compliance with the applicable requirements. Thus, the medical device manufacturer may commence an early-stage clinical study under the Investigational Device Exemption (IDE) framework. In this regard, the authority refers to the appropriate guidance document.
The Agency uses the term “leapfrog guidance” to emphasizes that the present document describes its current thinking on the matter. The authority reserves the right to change the recommendations provided if deemed reasonably necessary in the context of new information made available to the FDA. As mentioned, the Agency also recommends using the Q-Submission pathway to obtain preliminary feedback from the authority. The document also contains references to the FDA-recognized voluntary consensus standards the medical device manufacturers may use to demonstrate compliance with the applicable regulatory requirements.
The scope of the guidance does not cover non-implanted BCI devices due to the fact that the regulatory requirements applicable thereto are different in comparison to the ones addressed in the present guidance, especially the ones related to the technical characteristics and indications for use. For such devices, the Q-Submission pathway could be applied by the interested party in order to obtain device-specific feedback from the regulating authority. Additionally, if the medical device in question has some components or features that are not covered by the scope of the present document, the Agency also recommends its manufacturer to discuss all related aspects in advance.
Pre-Submission & IDE Recommendations
First, the present FDA guidance outlines the scope of information to be provided by the medical device manufacturer regarding the BCI device subject to review. According to the document, such information shall include:
- A complete description of every module of the device. Since the devices of this type consist of several modules, each of them should be described in detail.
- A general overview of the BCI device as a whole system, including a description of how the different modules are configured to comprise the whole system and, if applicable, a description of the different system configurations.
- A complete description of key components of the device, including its function, relevant model numbers, materials, location (implanted or external component), and dimensions or sizes that a user would need to know to use the device properly. If the product subject to review constitutes a medical device already placed on the market, but with certain modifications made, such modifications should be described in detail.
- A thorough description of interactions between the various components, the user and patient, and the environment.
- For a device that must be assembled or can be adjusted prior to use, an “exploded” view of the individual components relative to each other. The Agency additionally emphasizes that such a description should contain labels for any and all components indicated therein.
- For a device that includes software, a brief description of the software, including the various functions, prompts, user inputs, etc.
- For a device that incorporates radio frequency (RF) wireless technologies, a complete description of the exact wireless technology used, its characteristics, performance, risk management, and functions, including alarm conditions. In this context, the Agency refers to the appropriate guidance on radio frequency wireless technology in medical devices, which provides additional recommendations and clarifications on the matter.
- A description of all safety features built into the device.
- For a device that applies electrical current to the muscle or nerves, the output stimulation characteristics should be provided.
- All devices intended to be used in conjunction with the implanted BCI device and whether the devices are packaged or sold with the implanted BCI device should be described. Therefore, if a BCI device is supplied together with some other medical devices, the medical device manufacturer shall provide detailed information about such medical devices as well. The scope of this information shall cover the description of design and composition.
Additional Aspects
Apart from the key points outlined above, the present FDA guidance describes some additional aspects to be taken into consideration by the medical device manufacturers in the context of BCI devices. For instance, the Agency mentions that the manufacturer shall also provide information related to risk management describing the identified risks associated with the medical device in question, as well as the measures taken to mitigate such risks and overall residual risk – the risk that reasonably cannot be mitigated.
According to the document, the risk analysis shall include:
- A qualitative examination of the potential hazards, and
- Identification of hazards caused by single-fault conditions.
Thus, the Agency expects to receive a detailed description of the precautions and special measures taken to address the risks identified, together with the appropriate justification.
In summary, the present guidance describes the most important regulatory matters related to BCI devices. In particular, the document describes the scope of information to be provided to the regulating authority in the course of preliminary discussions and the application process itself.
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