The article provides an overview of the US regulatory framework regarding the electromagnetic compatibility of medical devices.
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 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, it is important to mention that FDA guidance documents are non-binding, and are not intended to introduce new rules or impose new requirements. Moreover, an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance. The present guidance constitutes a final version based on the draft issued by the authority earlier in November 2020.
The guidance is intended to provide recommendations regarding the scope of information to be included in premarket submissions concerning the matters related to electromagnetic compatibility. The said recommendations are applicable in the context of such submissions as premarket approval (PMA) application, humanitarian device exemption (HDE), premarket notification (510(k)) submission, investigational device exemption (IDE), De Novo request, and some of the biologics license application (BLA) and investigational new drug (IND). The document describes the way the manufacturer may demonstrate electromagnetic compatibility for electrically-powered medical devices and medical devices with electrical or electronic functions. As further explained by the FDA, the evaluation of the EMC-related information should be based on the risks associated with the potential malfunction of the device and the consequences thereof. The document also contains references to the FDA-recognised voluntary consensus standards medical device manufacturers may use when demonstrating compliance with the applicable regulatory requirements.
Thus, the scope of the guidance covers medical devices, including the in vitro diagnostic ones, that are electrically-powered; or have functions or sensors that are implemented using electrical or electronic circuitry.
The guidance becomes applicable within 60 days from the date it was issued for all non-IVD products covered by its scope.
According to the guidance, electromagnetic compatibility stands for 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 excessive EM disturbances (i.e. emissions) that might interfere with other equipment; while the immunity is the ability to protect against unacceptable degradation due to EM disturbances such as radio waves, power surges, radiofrequency (RF) disturbances, and electrostatic discharge ESD). The aforementioned interferences could adversely impact the operations of medical devices and result in hazards for customers, healthcare professionals, and patients. As a result, medical devices could operate not as intended when used for the initial purpose. Apart from that, there are emissions limits intended to ensure correct operations of radio services and all devices, including non-medical ones. The authority also refers to the IEC 60601/80601 and IEC 61010 series of standards to be applied concerning the devices covered by the scope of the guidance. The aforementioned standards outline the general requirements medical devices should meet in terms of electromagnetic compatibility and prevention of interferences.
As it was mentioned before, for electrically-powered medical devices and medical devices with electrical or electronic functions, [the manufacturer] should provide evidence that the medical device is safe and performs as intended in the environment of use.
EMC Information for Premarket Submissions: Key Points
The document further highlights the key points to be addressed in the documentation to be submitted by the applicant concerning EMC-related matters. The appropriate information should be provided in the respective sections of the submission and contain references to corresponding documentation. At the same time, some of these elements could be included in test reports or test summaries – in such a case, the appropriate references should be provided as well.
EMC-Related Device Characteristics and Intended Use Environments
First of all, the information should cover the characteristics of the medical device in question-related to the electromagnetic compatibility and the particular environment in which the device is intended to be used. In this respect, the submission should include, inter alia, the following elements:
- An overview of the device and its functions and modes, including block diagrams, photographs, cables, relevant accessories, and device interoperability;
- A description of the power supply, including if the internally-powered medical device can be used while charging;
- A statement regarding the environments in which the medical device is intended to be used;
- A description of any wireless technology; and
- A description of any intentional RF emitters in the medical device that could be sources of EM disturbances.
The indication of the particular environment in which the device is initially intended to be used is important for determining the scope of testing to be performed to evaluate the EMC-related matters. According to the guidance, potential use environments include the following ones:
- Professional Healthcare Facility Environment – hospitals, laboratories, and all other facilities where experienced and trained staff can continuously oversee the operations of medical devices.
- Home Healthcare Environment – a setting where the device is not under the continuous supervision of a properly trained and qualified person.
- Special Environment – the one which has specific EM characteristics in comparison to the general ones described in the appropriate standard. For instance, this category includes military areas, aircraft, or medical treatment areas with high-powered medical devices (e.g., MRI).
As further explained by the FDA, when assessing the risks associated with the particular use environment, the manufacturer should collect and analyze the information about all the factors the device used in this environment will be subject to. For this purpose, manufacturers are encouraged to consider common EM emitters, as well as specific ones that could be present in the respective environments.
The document also describes the approach to be applied concerning risk assessment. In particular, it is stated that the manufacturers are expected to provide a summary description of the risks associated with malfunction, disruption, or degradation of the performance of the subject medical device due to EM disturbances. The scope of analysis to be performed by the manufacturer shall cover all issues and malfunctions that could potentially take place.
In summary, the present FDA guidance provides an overview of the regulatory requirements related to electromagnetic compatibility. The document highlights the key points to be considered by medical device manufacturers applying for marketing approval and outlines the scope of information to be included in the submission.
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