Device sponsors get detailed electromagnetic compatibility guidance from FDA

Regulatory NewsRegulatory News | 16 November 2020 |  By 

Medical device manufacturers have new draft guidance on electromagnetic compabitility from the US Food and Drug Administration (FDA). The new 20-page guidance delves into much more detail than the six pages of the 2016 final guidance it is destined to replace.
Electromagnetic compatibility (EMC) – the ability of a device to function safely and effectively in the electromagnetic environment in which it is intended to be used – includes both immunity to EM interference and non-interference of the device itself, explained FDA in the draft guidance.
In formulating the draft guidance, FDA’s Center for Devices and Radiologic Health (CDRH) and Center for Biologics Evaluation and Research (CBER) looked to the internationally harmonized International Electrotechnical Commission (IEC) 60601/80601 standards for devices used in patient care settings as well as ICE 61010-1 standards for laboratory settings. This full suite of standards lays out safety requirements for almost 100 specific device types.
“For electrically powered medical devices and medical devices with electrical or electronic functions, sponsors should provide evidence that the medical device is safe and performs as intended in the environments of use,” according to the draft guidance. “This evidence includes risk management with regard to EM disturbances [an analogous term to ‘interference’], testing, labeling, and other documentation, as recommended in this guidance.”
The guidance gives detailed instructions for sponsors about how to depict and describe the electromagnetic characteristics of devices, including the presence of any wireless technology and radiofrequency transmitters in the device. Risk assessment should take into account what would happen if EMI occurred, and categorize each harm to patient, user or operator according to the severity of potential harm.
Sponsors choosing to declare conformity to a standard should be cognizant of the extent to which FDA recognizes the consensus standard and submit “sufficient justification” if a non-recognized consensus standard is used. (RELATED: Voluntary consensus standards guidance updated by FDA, Regulatory Focus 14 September 2020)
In the draft guidance, FDA lays out in general terms consensus standards that might apply for three categories of medical devices: non-implantable medical devices, active implantable medical devices and “special environments.” The latter category might include, for example, devices meant to be used within a magnetic resonance imaging environment; here, “test methods specific to this potentially high-risk environment” are recommended.
“We recommend that the sponsor provide clear immunity pass/fail criteria,” said FDA, which also recommends a clear statement of essential performance for a device if applicable. These criteria, says the draft guidance “are fundamental to performing and assessing the adequacy of EMC testing to demonstrate that the medical device is safe and performs as intended.”
Sponsors should make sure that their testing includes all possible configurations, functions and modes for a given medical device if malfunction of the device under these different variations would cause unacceptable risk or prevent the device from functioning according to its intended use. New testing should be considered when the safety of a new version of a device cannot be supported by testing from the prior version.
The guidance reviews how to address allowances and deviations from standards and how to handle modifications, since even cosmetic changes can affect electromagnetic performance. The procedure for EMC information to support an investigational device exemption submission is also laid out in the draft guidance.
The ubiquity of EM emitters in a technology-rich environment such as a healthcare or laboratory setting makes it important that sponsors be “familiar with their intended use environments and reasonably foresee the potential for interference from emitters commonly found in those environments,” according to the guidance. Testing should use FDA-recognized consensus standards and labeling should reflect risks, mitigations and warnings stemming from the test results.
In an example of the level of detail addressed in the new draft guidance compared with the briefer guidance it will supplant, FDA gives detailed information about EMC-related labeling over the course of eight bullet points.

Comments on the draft guidance should be submitted by 19 January 2021, when the period of public consultation closes.


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Tags: devices, FDA, medical, US

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