The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the Brain-Computer Interface (BCI) devices. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to achieve and sustain compliance thereto. It is important to mention that due to the legal nature of the guidance the provisions contained therein are non-binding. Moreover, an alternative approach could be applied, provided such an approach complies with existing regulatory requirements and has been agreed with the authority in advance. The scope of the guidance covers, inter alia, the aspects related to clinical performance testing of BCI devices, and highlights the most important matters to be considered.
Report of Prior Investigations
Under the general rule, when applying for marketing approval under the FDA’s Investigational Device Exemption (IDE) framework, an applicant should submit a summary of prior clinical studies the product in question was subject. In the course of such clinical studies, the medical device subject to review should be used for its intended purpose initially determined by the manufacturer. In case clinical data for the particular device is not available yet, the applicant should provide any background clinical information already available. Such information could include data or publications on:
- Similar or related devices utilized for the proposed intended use; or
- The subject device or similar devices are used for different uses.
The FDA explicitly states that it is allowed to provide information deriving from the clinical use of a medical device in foreign countries. Such information should be summarised and provided in a structured way.
According to the guidance, an applicant should also provide a narrative description of each study containing the following details:
- The purpose of the study (e.g. proof of concept, patient perspective study);
- Whether the study was a pivotal, supporting, or feasibility study,
- The design of the study, including any randomization, building, and the control(s) used;
- The number of patients enrolled;
- The number of investigational sites both inside the United States (US) and OUS [Outside US];
- The primary study endpoint(s);
- The amount of available follow-up;
- A summary of results/conclusions.
Clinical Study Considerations
According to the guidance, the particular recommendations a sponsor of a study should follow depend on the particular device development stage, as well as the type of study. In this regard, the authority refers to the appropriate guidance documents describing specific matters. The Agency also mentions that implanted BCI devices covered by the scope of the present guidance are significant risk (SR) devices. The guidance further provides a non-exclusive list of regulations the studies related to BCI devices should comply with. According to the document, a party responsible for a study should describe and justify each of its elements. It is stated that adaptive trial designs could be applied when it is reasonable.
The aspects to be considered when developing the clinical study protocol include, inter alia, the following ones:
- Patient Populations. The Agency states that a variety of patient populations may benefit from BCI devices whose function is to augment their ability to interact with their environment and improve communication. Under the general rule, for the device to be allowed for marketing and use, the benefits associated with the device should outweigh the potential risks associated thereto. It is important to mention that the risk tolerance and needs could be different for various groups of patients. Thus, it is important to take into consideration the above mentioned factor to ensure the device meets the actual needs of the patient population it is intended to be used for, and the risks associated thereto do not exceed an acceptable level.
- Home Use. The authority also mentions that to ensure the accuracy and reliability of results obtained in the course of a study, it is important to conduct such a study in conditions that are similar to the ones the device in question is intended to be used in. Such an approach allows assessing the impact of all the factors the device could be subject to when used in a way prescribed by its manufacturer. This becomes especially important in the case of medical devices intended to be used at home – outside clinical settings. It is stated that in certain cases a caregiver will be required to perform the main operations with the device including the startup and maintenance, monitoring the progress, and also contacting healthcare professionals, should it be reasonably necessary to ensure the safety of patients. Hence, when conducting a clinical trial, a sponsor should also evaluate the aspects related to such use of the device. In particular, a caregiver should be able to assist the patient and ensure safety during the use. For this purpose, a sponsor should provide a detailed training program and outline the way its effectiveness will be assessed. In this regard, the authority also refers to the appropriate guidance dedicated to the specific matters associated with home use and describes the approach to be applied to mitigate the risks associated with such devices.
- Investigation Plan, which should cover such aspects as (i) the purpose/objective of a study, which should be determined in advance, (ii) study design, including the indication of its type and indication of the applicable success criteria, (iii) study duration and follow-up schedule describing the way the study will take place, and also the approach to be applied by a sponsor to evaluate effectiveness in a long-term perspective, (iv) inclusion/exclusion criteria to be applied to identify the particular patient population to be covered by the scope of a study and enrolment criteria, (v) patient demographics – this aspect is important since the demographic characteristics could impact significantly the reliability of the results of the study (vi) treatment parameters/protocol (including postoperative regimen), (vii) endpoints and other outcomes, including primary safety endpoints, primary and second effectiveness endpoints, as well as patient input.
- Informed Consent Document which should be in a form understandable for the average patient.
- Statistical Analysis Plan (SAP) Consideration.
In summary, the present FDA guidance describes in detail the most important aspects related to clinical trials for implanted BCI devices. The document outlines the scope of information to be submitted by the interested party when applying for marketing approval and also provides additional recommendations regarding the design of a clinical study to be considered to ensure the reliability of its results.
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