The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison.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. Coils intended for specific clinical indications or specifically intended for use with imaging agents are not included in the guidance.
Devices that qualify for the pathway do not need to provide direct comparison testing against a marketed predicate device to show they have “substantially equivalent performance characteristics,” the agency said.
Instead, the agency recommends providing a results summary for all tests evaluated along with other submission information identified for eight specific tests the agency describes in the guidance. The test information, including a results summary, test protocols, or complete test reports, should be submitted as part of the 510(k) application.
Read the draft guidance here: www.fdanews.com/12-06-19-MR-Coil-Safety-Guidance.pdf. — Jordan Williams