FDA Issues Draft Guidance On Electromagnetic Compatibility Of Medical Devices
By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of products for premarket submissions. FDA reviews these types of claims based on the risk of EMC malfunction or degradation of the device under review, and in accordance with industry standards.
EMC is defined as the ability of any electronically powered device to function properly in its intended electromagnetic environment without emitting any electromagnetic disturbances that could interfere with other devices’ proper functioning, according to Emergo.
Medical devices often operate in an environment that is increasingly crowded with potential sources of electromagnetic interference from other medical devices, home appliances, smartphones, wearables, and other gadgets. FDA wants manufacturers to comply with updated standards for EMC to help ensure device performance and protect public safety.
In premarket submissions, manufacturers of electrically-powered medical devices typically reference the International 77 Electrotechnical Commission (IEC) 60601-1-2 standard found in the FDA's Center for Devices and Radiological Health (CDRH) Recognized Consensus Standards database. They also use device-specific standards, such as IEC 60601-1, and International Organization for Standardization (ISO) 14708, for active implantable devices. For home-use devices, FDA recommends the ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02 standard.
In addition to conforming to aforementioned standards, FDA recommends that medical device companies requesting a claim of EMC include the following in their premarket submissions, according to the draft guidance:
- Summary of the testing that was performed to support EMC
- Specifications of the standard that were met (including immunity test levels)
- Device-specific pass/fail criteria used
- Specific functions of the device that were tested (e.g., for IEC 60601-1-2, this should include performance that was determined to be essential performance) and how these functions were monitored
- Performance of the device during each test, indicating if the device met the emissions and immunity pass/fail criteria
- Identification and/or justification for any of the standard's allowances that were used
- Description and/or justification for any deviations from the specifications of the referenced standard, and how deviations would not compromise the safety and performance of the device
- Device labeling and evidence of compliance with the reference standard's labeling specifications
- Description of all changes or modifications that were made to the device in order to pass any of the EMC tests, including full documentation of modifications in the design history file in accordance with design controls, and whether these are incorporated in the final production model
For applicant manufacturers, following the list of recommendations, EMC consensus standards, and related FDA guidance documents generally should be enough to prove a claim of EMC. However, FDA reserves the right to request additional information depending on intended use and intended use environment for specific active medical devices, according to the guidance.
FDA will accept written or electronic comments and suggestions through mid-December.