The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and authorization of medical devices.
In a Notice published in the Federal Register, the agency announced additions, withdrawals, and revisions to the list of FDA Recognized Consensus Standards. Notable among the more than 30 new standards added to the list is the addition of IEC 61326-1, which addresses general EMC requirements for medical electric equipment used for measurement, control, and laboratory use, and IEC 61326-2-6, which details EMC requirements specific to in vitro diagnostic devices.
Also newly added to the list of recognized standards is ANSI/AAMI 2700-1:2019, which covers essential safety requirements for medical devices and systems that incorporate software or other information technologies.
