USA – FDA adds transition period to electromagnetic compatibility final guidance

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 FDARegulatory Focus 16 November 2020)

The final guidance provides additional technical information to address issues in the 2016 guidance, according to FDA. It applies to electrically-powered medical devices and IVDs, and those that have functions or sensors that use electrical or electronic circuitry…