The Food and Drug Administration (FDA) has published amended draft guidance on electromagnetic compatibility (EMC) of medical devices. The Agency encourages the industry representatives and other parties involved in operations with medical devices to provide their comments and suggestions regarding the matter. The present guidance constitutes a draft document issued solely for the purpose of public consultations. Once finalized, this guidance will replace the appropriate FDA guidance “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” issued by the FDA earlier in July 2016.
Regulatory Background
The Agency states that the present guidance is intended to provide the interested parties with the additional clarifications and recommendations regarding the information to be included in a premarket submission related to the electrically powered medical devices and ones with electrical or electronic functions. The scope of the guidance covers a wide range of premarket submissions, including:
- Premarket approval (PMA) application,
- Humanitarian device exemption (HDE),
- Biologics license application (BLA),
- Premarket notification (510(k)) submission,
- Investigational device exemption (IDE), and
- De Novo request (a special pathway for entirely new medical devices).
Under the general rule, the FDA would assess the information on EMC in the context of the risks arising from malfunction or degradation resulting from EMC-related factors. The authority also mentions that the appropriate FDA-recognized voluntary consensus standards are also applicable and could be used by the medical device manufacturers in order to demonstrate conformity with certain requirements.
The Agency also emphasizes that the new guidance does not change the existing approach to electromagnetic compatibility of medical devices, it is intended to expand some technical aspects.
The scope of the present FDA guidance on EMC covers medical devices, as well as accessories thereto, which:
- are electrically powered, or
- have functions or sensors that are implemented using electrical or electronic circuitry.
Electromagnetic Compatibility of Medical Devices in Detail
According to the guidance, electromagnetic compatibility is the ability of a medical device to function safely and effectively in its intended electromagnetic (EM) environment, including immunity to EM disturbances (i.e., interference), without introducing excessive EM disturbances (i.e., emissions) that might interfere with other equipment.
In this context, immunity should be defined as the ability of a medical device to withstand the impact of various electromagnetic disturbances (e.g. radio-frequency disturbances, electrostatic discharge, power surges, etc.). Electromagnetic compatibility aspects are important since in some cases the aforementioned interferences could impact the normal operations of a medical device, creating hazards to the health of a patient. It is also important to mention that in order to minimize interference, the emission limits have been implemented.
The appropriate requirements are also established by the international standards IEC 60601/80601 series for patient care settings medical devices, while the ones intended to be used in laboratory settings are covered by the IEC 61010-1 series. The aforementioned standards are used in most submissions in order to demonstrate the conformity of a medical device in question with the applicable requirements since they cover a wide range of hazards including, inter alia, the electrical, mechanical, and radiation ones. Moreover, these groups of standards also include numerous device-specific standards dedicated to certain types of medical devices. The Agency also mentions that some of the standards related to active implantable medical devices (AIMD) also address electromagnetic compatibility issues.
Under the general rule, the FDA requires the medical device manufacturer or another party intended to place a new device on the market to provide sufficient information confirming that the medical device in question could operate safely and in a normal way in the intended use environment. For this purpose, the applicant shall supplement the submission with risk management covering the aspects related to the electromagnetic disturbances. The present guidance also outlines other documentation to be provided, including the one related to testing and labeling. The Agency states that it is important to include all necessary information in the initial submission in order to simplify and accelerate the review procedure.
EMC Information for Premarket Submissions
As it was already mentioned before, the present FDA guidance describes the scope of information regarding the electromagnetic compatibility matters. In particular, the Agency expects the applicant to provide the following:
- EMC-related device characteristics and intended use environments. In this section, the applicant shall describe all functions and modes of the device, its power supply, wireless technologies, and radiofrequency emitters, and also provide a statement regarding the particular environment the medical devices in question should be used in. The intended use environments could include a Professional Healthcare Facility Environment, a Home Healthcare Environment, or a Special Environment.
- Assessment of medical device risks. The applicants are expected to provide information about all the risks associated with possible malfunctions of the medical device that could be potentially caused by the electromagnetic disturbances. This information should be provided in a structured way in the form of a summary. Under the general rule, the risks are divided into three categories (levels) depending on the severity of the consequences, and thus should be described accordingly.
- Consensus standards. As it was mentioned before, the medical device manufacturers may refer to the FDA-recognized voluntary consensus standards in order to demonstrate conformity with the applicable safety and performance requirements. Thus, the manufacturer shall provide the appropriate references to the consensus standards used to address the electromagnetic compatibility aspects. In case if the particular standard is not recognized by the FDA, the manufacturer will have to provide more details regarding the EMC testing performed. The Agency also places an emphasis on the importance of the proper use environment to be considered when applying the voluntary standards.
- Essential Performance and immunity pass/fail criteria. It is important to indicate clear immunity pass/fail criteria used when assessing the device with regard to electromagnetic compatibility issues. In this section, the applicant shall also describe the performance limits and provide the evaluation of the risks, associated with the potential deviations.
- Medical device configuration and functions tested. The applicant shall also provide a detailed description of the particular medical device subject to testing, including its configuration, functions, and modes. This information is important when evaluating the reliability of testing performed.
- Results of EMC testing. The appropriate summary should be provided, including the indication of test levels. Such a summary shall include, inter alia, the following information: name and location of the facility where the testing has been performed, testing date, results for each emission, and immunity test. It is important to mention that the aspects related to the potential deviations and the way the device operates in such cases should be also covered.
- Allowances – specifications describing acceptable variations.
- Deviations – all intentional non-compliance with the applicable standard, together with the justification of each deviation.
- Modifications. The applicant shall describe in detail any and all modifications made to the device and its components, and also the way such modifications actually impact the safety and performance of the device in the context of electromagnetic compatibility.
- Common EM Emitters. In this section, the applicant is expected to describe the impact caused by known EM emitters associated with the particular use environment.
- Labeling. According to the guidance, the information on electromagnetic compatibility should be included in the labeling of the device.
Summarizing the information provided here above, the present FDA guidance on electromagnetic compatibility of medical devices describes the current approach to EMC-related matters, as well as the information to be included in the premarket submission. In particular, the document contains recommendations regarding the scope and format of the information to be provided.
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