The Center for Devices and Radiological Health (CDRH) released a guidance document Aug. 21 to establish the safety and compatibility of passive implants in the MR environment.
Specifically, the guidance applies to MR devices that serve their function without the supply of electronic power. It is intended as a guide for vendors in preparing a premarket approval application (PMA), investigational device exemption (IDE) and premarket notification 510(k) submission.
The document addresses testing and labeling of passive implants for MRI and document.
The agency has recommended that vendors provide nonclinical testing information for PMA, IDE or 510(k) to establish the safety and compatibility of the passive implant for MRI. Testing should encompass the range of sizes of the device intended for marketing.
Regarding labeling requirements, the guidance provides advice on whether passive implants are safe in all MR environments or whether things like magnetically induced displacement force and torque, radio frequency heating and image artifacts should be taken into account to ensure patient safety, according to the CDRH.