The new article describes in detail specific aspects of electromagnetic compatibility, including the ones related to modifications and labeling.
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 the electromagnetic compatibility (EMC) of medical devices. The document describes the regulatory approach to be applied and also provides additional clarifications regarding the existing regulatory requirements. Provisions of the document are non-binding and are not intended to introduce new rules or impose new obligations, but rather to assist medical device manufacturers and other parties involved in achieving and sustaining compliance with the respective requirements set forth under the existing framework. The authority also mentions that an alternative approach could be applied, provided such an approach is in line with the current legislation and has been agreed with the FDA in advance.
According to the document, in the case certain changes were made to the device, allowing it to pass the EMC testing after the initial failure to do so, detailed information about such changes should be duly provided by the manufacturer. These changes could be related to various elements and components of the device in question (e.g., hardware, software). For instance, the manufacturer may add shielding materials or update the software. As further explained by the FDA, concerning the changes intended to ensure the device will pass the EMC testing, the following details should be provided:
- A description of all changes or modifications that were made to the medical device to pass EMC testing;
- A statement of whether the provided EMC test results occurred before or after the modifications were incorporated into the medical device. If EMC testing was not performed after the modifications were made to the medical device, risk analysis and scientific justification should be provided that the modified medical device does not adversely impact the safety or performance of the medical device.
- A statement indicating that the changes will be incorporated into the final finished medical device before marketing; the changes must be documented in the design history file following design controls.
- An analysis as to whether these modifications might impact other aspects of the medical device safety or performance, such as whether they increase risks to patients or operators, alter the biocompatibility or sterility, affect electrical safety, or introduce software anomalies/defects.
The authority expects the above information to be addressed in the documentation submitted by the applicant to ensure the FDA has all the details necessary to assess the impact of changes and risks associated thereto.
Common Electromagnetic Emitters
The document further describes the approach to be applied concerning electromagnetic (EM) emitters that are common for the environment in which the device in question is intended to be used. In this respect, the authority mentions that not all of the environments are properly covered by the FDA-recognized voluntary consensus standards. Sometimes this happens due to the rapid technological development resulting in changes to the EM environment. Hence, to ensure proper operations of medical devices, the manufacturer shall consider carefully the EM factors associated with the EM environment the device is intended to be used in, identify the EM emitters and assess the impact they may cause on the device’s operations. The manufacturer shall analyze all foreseeable interferences and assess the impact they could potentially cause.
According to the guidance, the examples of EM emitters that are not covered properly by the FDA-recognized consensus standards are radiofrequency identification (RFID) readers, electronic security systems, near-field communications (NFC) systems, wireless power transfer (WPT), Cellular 5G, and unique medical emitters such as electrocautery, MRI, electrosurgical units, and diathermy equipment. The impact of the abovementioned factors should be considered by medical device manufacturers to ensure the safety and effectiveness of their products when used for the intended purposes in the respective environment. The approach to be applied by the manufacturer should be based on the risks associated with the intended use environment, and also on the severity of potential consequences. The appropriate warnings and precautions should be also included in the labeling, which should provide all the necessary information about the risks and measures to be taken to mitigate them. Any claims made by the manufacturer concerning EMI-related matters should be duly justified. For this purpose, the manufacturer may refer to the results of additional analysis or testing performed by the applicable voluntary consensus standards.
The authority also describes in detail the approach to be applied concerning labeling which, as was mentioned before, should reflect the important information to be communicated to end-users. For instance, the labeling could explain the way the devices should be selected in the context of EM-related factors. The details on EMC provided in the labeling could be used by the potential users to prevent issues related to the impact of EM disturbances the device could be subject to when used in the intended use environment. The authority expects the manufacturers to provide details about the EMC-related information to be included in labeling when applying for marketing approval. The said information should correspond to the applicable consensus standards. According to the guidance, the labeling should include, inter alia, the following details:
- The environments of use for which the medical device is suitable to be used/exposed.
- Accessories and other equipment with which the device has been determined to be compatible.
- The medical device’s functions/performance and a description of what the operator can expect if the functions/performance are lost or degraded due to EM disturbances.
- The compliance level for each emission and immunity test.
- The use of any deviations from, allowances specified by, the referenced standards.
The document further outlines other details to be included in labelings, such as precautions or specifications.
In summary, the present FDA guidance describes an approach to be applied when providing EMC information related to modifications or changes to a medical device. The document also outlines the scope of information to be provided in labeling to ensure that all the important warnings and precautions are duly communicated to the intended users.
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