The U.S. Food and Drug Administration (FDA) has proposed a revision to performance and safety information in 510(k) submissions for certain MRI coils.
The draft guidance would eliminate the need for air-cooled, receiver-only radiofrequency coil vendors and manufacturers to "provide direct comparison testing against a legally marketed predicate device to demonstrate substantially equivalent performance characteristics," according to the FDA. Instead, the agency would have these entities submit a 510(k) application, which provides a summary of all test results in addition to current standards that include surface heating, image quality, and electrostatic discharge.
MR coils are evaluated as class II devices and are regulated under 21 CFR 892.1000 as an MR diagnostic device.
