The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to sponsors who wish to submit a 510(k) application using the agency’s Safety and Performance Based Pathway.
The guidance covers Class II MR coils that are intended for hydrogen/proton imaging for general diagnostic use. The devices are not meant to make contact with patients, and if they do, it should be limited contact with intact skin, the agency said.
Devices that qualify for the pathway do not need to provide direct comparison testing against a predicate device to show they have “substantially equivalent performance characteristics,” the agency said.