The Food and Drug Administration (FDA) has published a guidance document dedicated to the cutaneous electrodes for recording purposes. In particular, the document constitutes a final version of the guidance, while the initial draft was published by the FDA in September 2019. Due to its legal nature, this guidance does not establish mandatory requirements that the parties involved in operations with medical devices shall follow. Rather, it only provides certain recommendations and clarifications.
Regulatory Background
The present FDA guidance outlines the core performance criteria for cutaneous electrodes to be applied in the context of the Safety and Performance Based Pathway. It is stated that when filing a 510(k) submission under the aforementioned special framework, the applicant is allowed to refer to the comparison based on performance criteria. The Agency explains that such an approach could be used instead of direct comparison with the predicate (a similar medical device already placed on the market) as required under the general rule.
According to the guidance, the cutaneous electrodes are non-invasive, single-use electrodes designed for recording purposes. Such devices are intended to be used on normal, healthy, clean, and intact skin. In accordance with the general rule, the cutaneous electrodes are Class II medical devices under the risk-based classification, and thus are subject to regulation under 21 CFR 882.1320. The product code to be assigned to such devices is GXY.
The FDA first describes the intended purpose of medical devices covered by the scope of the guidance. The cutaneous electrodes are intended to be used for recording physiological signals in the context of the electroencephalogram or electromyography.
The FDA additionally emphasizes that some of the cutaneous electrodes are actually falling outside the scope of the present guidance. In particular, the Safety and Performance Based Pathway should not be applied if the medical device in question is intended to/for:
- Deliver stimulation,
- Use in an MR environment,
- The intended use covered by any other regulation,
- Be reused,
- Be used without any electroconductive media (dry electrodes).
Cutaneous Electrodes Design Characteristics
As stated before, the cutaneous electrodes covered by the scope of the present FDA guidance are intended for non-invasive use on intact skin. The FDA also states that such electrodes could also have special electroconductive media, otherwise the manufacturer may refer to the electroconductive media already placed on the market separately if such media is intended to be used with the electrode. However, the scope of the present guidance covers only the cutaneous electrodes themselves, and not the electroconductive media devices.
According to the guidance, the cutaneous electrodes should be designed on the basis of the details regarding their intended use and the site they should be applied. The manufacturer should also take into account the use of specifics based on the needs of the patients belonging to the different age groups – in particular, special sizing should be available for adults and children.
The FDA reserves the right to require the applicant to provide additional information to supplement the application if it would be reasonably necessary for the authority to assess the case in general, and to determine the eligibility of the device for the Safety and Performance Based Pathway in particular. The applicants are also encouraged to submit a Pre-Submission to commence communications with the authority before filing the application itself since this will allow them to save additional time and accelerate the whole process.
Testing Performance Criteria
In accordance with the FDA guidance, when applying under the Safety and Performance Based Pathway, the applicant is not required to provide a direct comparison with the predicate device in order to confirm that the device subject to review complies with any and all applicable safety and performance requirements. When filing a submission, an applicant shall provide the authority with the appropriate summary of test results, together with the other information required to be provided (such as a Declaration of Conformity). In particular, the applicant shall submit test protocols or complete test reports. When describing the applicable requirements and regulations, the FDA also refers to the appropriate guidance on the recommended content and format of non-clinical bench performance testing information in premarket submissions.
The Agency recommends using the following structure to provide the information:
- Test name,
- Methodology,
- Performance Criteria,
- Performance Criteria Source,
- Submission Information.
Biocompatibility Requirements
Another important aspect to be considered by the medical device manufacturer in the case of the cutaneous electrodes relates to biocompatibility. Due to the nature of the aforementioned devices, biocompatibility evaluation becomes an important part of the evaluation process. In the context of biocompatibility, the cutaneous electrodes are classified as “Surface Devices.” Thus, the following points should be addressed:
- Cytotoxicity,
- Sensitization,
- Irritation or Intracutaneous Reactivity.
There are certain specific rules simplifying the process of demonstrating compliance with the aforementioned requirements. For instance, if the cutaneous electrode subject to review comprises from the same materials as a similar electrode already approved by the FDA and properly placed on the market, it would be sufficient to make references to such a predicate, providing that any differences in the design of the devices do not impact its biocompatibility characteristics. Thus, in such a case, the references to the equivalent biocompatibility are allowed. It is important to mention that the duration of tissue contact and its type should be the same for both new devices in question and the predicate.
If additional testing is reasonably necessary to evaluate certain important aspects related to the safety and performance characteristics of the device in question, the applicant shall provide the FDA with complete test reports covering all the tests conducted before filing the submission, or provide a complete declaration of conformity. The applicant shall also properly describe and all deviations from test protocols and provide the appropriate justifications. The FDA also emphasizes that certain deviations could result in the inadmissibility of the medical device in question for the Safety and Performance Based Pathway, so the applicant would have to use a Traditional, Special or Abbreviated framework instead.
Summarizing the information provided hereinabove, the present FDA guidance describes the requirements to be applied for the cutaneous electrodes in the context of submitting an application under the Safety and Performance Based Pathway. In particular, the document provides the applicants with the additional clarifications and recommendations regarding the scope of medical devices eligible for the aforementioned framework, the documents, and information to be submitted, and also on the device-specific requirements the cutaneous electrodes should meet. The FDA pays special attention to the issues related to biocompatibility, which becomes especially important in the case of patient-contacting medical devices.
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