The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility (EMC) in connection with medical devices, including in vitro diagnostic (IVD) devices.
Posted to the FDA’s website, the final guidance, titled “Electromagnetic Compatibility (EMC) of Medical Devices,” provides details on EMC-specific issues that device manufacturers should consider in advance of submitting their devices for review under the FDA’s premarket submission process. Specific issues to consider include EMC-specific characteristics in the context of the device’s intended use environment, and performance testing results.
The final guidance replaces the initial draft guidance issued in November 2020, as well as a 2016 guidance titled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically Powered Medical Devices.”
The final guidance applies to all electrically powered medical devices and IVDs. Device manufacturers will have 60 days to address the provisions of the guidance in new device submissions, while IVD device manufacturers will be provided with up to one year to ensure alignment with the provisions of the guidance.