The US Food and Drug Administration (FDA) has finalized guidance on medical device electromagnetic compatibility that replaces a 2016 document on the same topic. While the agency is giving medical device sponsors 60 days to adopt the guidance, in vitro diagnostic (IVD) makers will have a year to conform to it.
FDA finalized its Electromagnetic Compatibility (EMC) of Medical Devices Guidance last week, after releasing the draft version for comment in November 2020. The guidance outlines what sponsors need to consider about potential electromagnetic interference and immunity from or with their device and will supersede the June 2016 guidance titled Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices after the 60-day and 1-year implementation period for IVDs and other medical devices, respectively. (RELATED: Device sponsors get detailed electromagnetic compatibility guidance from FDA, Regulatory Focus 16 November 2020)
The final guidance provides additional technical information to address issues in the 2016 guidance, according to the FDA. It applies to electrically-powered medical devices and IVDs, and those that have functions or sensors that use electrical or electronic circuitry.
FDA is giving IVD sponsors additional time to adopt the guidance with the understanding that they may need up to a year to perform activities to operationalize the policies set in it. But for other medical devices, the agency says sponsors will have 60 days to adopt the guidance.
“If new information regarding electromagnetic compatibility as outlined in this guidance is not included in a premarket submission for an in vitro diagnostic received by FDA before or up to 1 year after the publication of this guidance or for other device types within the scope of this guidance before or up to 60 days after the publication of this guidance, FDA does not generally intend to request such information during the review of the submission,” the agency added. “FDA does, however, intend to review any such information if submitted.”
The guidance lays out what is expected of sponsors in terms of EMC information they provide in their premarket submissions, such EMC-related characteristics of their product, their intended use environments, what consensus standards the products follow, performance testing data and labeling requirements.
A key consideration of the guidance is the use of consensus standards. In particular, the guidance repeatedly references the IEC 60601/806018 series of standards which apply to medical devices and systems that directly apply or transfer energy to the patient and are used in lab equipment.
“These standards are used in the majority of premarket submissions for electrically-powered medical devices to support device safety,” FDA notes. “These standards attempt to address all hazards (eg, mechanical, electrical, radiation). Besides addressing the wide range of generic safety requirements, the IEC 60601/80601 and IEC 61010 series include close to 100 ‘particular standards’ with safety requirements for specific types of devices, such as clinical thermometers, infusion pumps, infant incubators, laboratory centrifuges, medical device sterilizers and reprocessors, and medical washer-disinfectors.”
When sponsors use consensus standards in their submissions that are not recognized by FDA, the agency says they need to provide justifications for how the EMC testing performed addresses the agency’s requirements. In cases where there are no consensus standards, FDA recommends specific EMC testing for foreseeable electromagnetic disturbances in the environment the product is intended to be used in.
“We recommend referencing an existing FDA-recognized consensus standard for a similar medical device type and environment and modifying the test specifications in the standard to address the subject medical device,” the FDA said. “Each change in test specification should be documented and accompanied by justification.”
“When using consensus standards, we recommend verifying that the intended use environments are adequately addressed by the standards,” the agency added. “Many consensus standards only address and specify test levels for the home healthcare environment and the professional healthcare facility environment.”
The guidance also breaks down what the different environments devices may be used in and how the level of care and the potential electromagnetic disturbances in those environments need to be taken into consideration.
FDA recommends sponsors provide clear electromagnetic immunity pass/fail criteria for their products and a clear statement of its Essential Performance. The agency says the criteria are fundamental for reviewers to assess the adequacy of the EMC testing in order to determine the safety and performance of such products.
“Immunity pass/fail criteria should address the impairment of the medical device’s functions caused by the test disturbance,” the FDA said. “Your EMC test plan should specify which degradations are considered acceptable.”
The agency recommends sponsors specify detailed immunity pass/fail criteria that are quantitative, specific to the medical device and functions and observable.
“These criteria should be determined based on the medical device’s functions, modes, indications for use, intended use, and Essential Performance (if applicable),” FDA said. “If a medical device has multiple medical device subsystems … or more than one function … then each medical device subsystem or function can have specific immunity pass/fail criteria.” We recommend that you specify how the immunity pass/fail criteria were derived, quantified, and monitored, and justify how they demonstrate that the medical device remains safe and performs as intended.”
In addition to considering all the potential electromagnetic interference from devices in any intended use environment such as magnetic resonance imaging (MRI) machines in hospitals, FDA also wants sponsors to think about other potential devices such as cell phones and tablets that may interfere with their products .
Another typically important area to consider for the FDA is how sponsors intend to label their products, so physicians and patients understand the limitations of their products as well as any potential risks.
“It is important to include EMC-related information in the labeling because EMC testing alone may be insufficient to mitigate the risk associated with use in all environments,” the agency said. “Providing EMC information in the labeling (eg, instructions for use) can help make users aware of the degradations that can be caused by EMI and to understand the circumstances to avoid. We recommend that the submission include EMC information to be included in the labeling to enable safe and effective installation and use of the medical device in the intended EM environments over the expected service life.”
Besides typical premarket submissions, the guidance also addresses EMC considerations for medical devices used in investigational device exemption (IDE) and investigational new drug (IND) applications. The agency says it understands that due to design iterations of products in clinical studies, sponsors may not be able to provide comprehensive EMC information. It also notes that other EMC mitigation actions may be more appropriate to make benefit/risk determinations.
“If immunity testing has not been performed using appropriate consensus standards … for the medical device under study, you should provide in the IDE or IND submission, a description of alternative mitigations, such as ad-hoc testing and a list of labeling mitigations (eg , continuous oversight from medical professionals, procedures to prevent harm to operators, ESD mitigation precautions) along with an explanation of how the mitigations protect the safety of patients and operators,” the FDA said. “If emissions testing has not been performed for the medical device under study per appropriate consensus standards, then you should provide in the IDE or IND submission a description of potential risks to patients and operators in case the subject medical device introduces excessive emissions that might interfere with other medical or non-medical equipment. This should include a justification about how each risk will be mitigated.”
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