The new article describes in detail the scope of information to be included in the premarket submission concerning electromagnetic compatibility.
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 electromagnetic compatibility (EMC) for medical 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 ensure compliance thereto. At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new obligations. The authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
The document describes, inter alia, the approach to be applied concerning voluntary consensus standards to be used when demonstrating compliance with the applicable regulatory requirements. In particular, the authority encourages medical device manufacturers to conduct testing related to EMC under the requirements, set forth by the respective standards. Should the manufacturer decide to follow such an approach, the submission should include all the information required regarding the way the standard is applied as described in the respective FDA guidance “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices”. In this regard, it is also important to consider the date of recognition of the respective standard and its version. Should the manufacturer decide to refer to the standard which is not recognized by the FDA, the appropriate justification should be provided. In particular, it would be necessary to explain how the EMC testing performed adequately addresses EMC, based on the medical device’s functions, modes, indications for use, intended use, and intended use environments. The authority also mentions that in case there are no device-specific standards for a particular device type, the testing to be conducted should be based on the EM disturbances the product is expected to face in the intended use environment. The manufacturer may also provide references to the standard applicable to similar medical devices and make changes to the testing methods to accommodate the specific features of the device in question.
The authority additionally emphasizes the importance of ensuring the that standard to be applied covers the intended use environment, since many consensus standards only address and specify test levels for the home healthcare environment and the professional healthcare facility environment. Another important aspect to be considered when determining the applicability of a particular voluntary consensus standard is the configuration of the device in question.
The document further describes in detail the way the applicable standards should be determined. According to the guidance, the three main categories are:
- Non-implantable Medical Devices;
- Active Implantable Medical Devices (AIMDs); and
- Special Environments.
The guidance explains the approach to be applied concerning each of these categories and outlines the main standards to be applied.
Essential Performance and Immunity Pass/Fail Criteria
According to the guidance, the information to be provided should include the details regarding the pass/fail criteria the manufacturer applies when assessing the EMC-related aspects. In this respect, the authority points out the following aspects:
- Essential Performance. According to the standard ANSI/AAMI/ES 60601-1:2005, the Essential Performance stands for the performance of a clinical function, other than that related to Basic Safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk. As further explained by the FDA, the Essential Performance should be determined by:
- Identifying the performance of the clinical functions,
- Specifying performance limits for fully functional performance versus loss or degradation of the identified performance, and
- Evaluating the risk from the loss, disruption, deviation, degradation, or over-delivery of the identified performance.
- Immunity Pass/Fail Criteria describe the degradation of the product’s functions due to the impact caused during the test. When planning testing, the manufacturer should determine the extent to which such degradation would be deemed acceptable. According to the guidance, the criteria to be used should be quantitative, specific to the product in question and its functionality, and also observable. The aspects to be considered when determining the applicable criteria include, inter alia, the intended use of the device subject to review, its functions, and Essential Performance. It is also important to mention that in the case of complex products (systems) comprised of several products, each of the products should be assessed separately using product-specific criteria. The authority additionally emphasizes that the criteria to be applied concerning accidental and continuous factors could be different. The assessment approach would be different as well: when assessing the impact of accidental factors, the manufacturer would evaluate the safety and performance of the device after the event, as well as recovery time; while in case of continuous factors the device should operate safely and efficiently even being exposed to the said factor. It is also stated that some of the applicable standards already provide examples of immunity pass/fail criteria, or at least outline the general approach to be followed. At the same time, such criteria are not product-specific and do not reflect the specific features of the medical device in question. The authority provides an example of the situation when similar medical devices could be subject to different pass/fail criteria just due to the difference in the intended use. Thus, some of the applicable standards cover both Basic Safety and Essential Performance, while others address only one of the above mentioned aspects. Hence, the authority encourages medical device manufacturers to determine the applicable immune pass/fail criteria by considering the most important specific features of the device in question, including its intended use, indications for use, type, functionality, and other matters.
In summary, the present FDA guidance provides an in-depth review of the applicable regulatory requirements in terms of electromagnetic compatibility for medical devices and specific aspects to be considered in this regard. The document also clarifies the approach to be followed when deciding on the applicability of the voluntary consensus standards.
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