April 6, 2023

Don’t Claim Device MR Compatibility Until You’ve Earned It

For the United States, if a device doesn’t yet have FDA-cleared/approved MR labeling, then it would constitute misbranding (illegal labeling) if a letter or other promotional or instructional information is sent to customers stating that the device is MR safe.  In short, this is because a) such a customer letter meets FDA’s statutory definition of labeling; b) if a letter (or other labeling) promotes a device as being MR safe when in fact the sponsor hasn’t actually yet completed and vetted the required MR compatibility testing, then that constitutes an unsubstantiated claim thereby violating FDA’s labeling law, and c) MR labeling is an attribute that needs FDA premarket authorization [e.g., 510(k)-clearance, PMA approval, etc.] before being used for marketed devices.