Electrode lead wire reg based on international standards sought by device manufacturers.
This article was originally published in The Gray Sheet
Executive Summary
PATIENT ELECTRODE LEAD WIRE REGULATION BASED ON VOLUNTARY STANDARDS is recommended by Medtronic, Bard, and 3M Health Care in recent comments on FDA's proposed mandatory performance standard for the devices. "In lieu of a mandatory performance standard," Medtronic says, FDA should require manufacturers of electrode lead wires to "certify that their leads comply with a recognized voluntary standard when a device is reviewed through the 510(k)" or premarket approval process.