Magnetic Resonance Coil Performance Criteria Guide

Federal Register notice: FDA has made available a draft guidance on “Magnetic Resonance (MR) Coil — Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for MR coils to use for clearance under the agency’s Safety and Performance Based Pathway. Under the framework, if a legally marketed device performs at certain levels relevant to its safety and effectiveness, and a new device meets those levels of performance for the same characteristics, FDA could find the new device safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device. To view the notice, click here.