USA – Device sponsors get detailed electromagnetic compatibility guidance from FDA

Medical device manufacturers have new draft guidance on electromagnetic compabitility from the US Food and Drug Administration (FDA).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to be used – includes both immunity to EM interference and non-interference of the device itself, explained FDA in the draft guidance.
 
In formulating the draft guidance, FDA’s Center for Devices and Radiologic Health (CDRH) and Center for Biologics Evaluation and Research (CBER) looked to the internationally harmonized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provide evidence that the medical device is safe and performs as intended in the environments of use,” according to the draft guidance.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.”…