MANDATORY PERFORMANCE STANDARD FOR DEVICES WITH ELECTRODE LEAD WIRES PLANNED
This article was originally published in The Gray Sheet
Executive Summary
MANDATORY PERFORMANCE STANDARD FOR DEVICES WITH ELECTRODE LEAD WIRES PLANNED by FDA, according to an advance notice of proposed rulemaking published in the May 19 Federal Register. Promulgation of a performance standard, the agency says, is among the special controls necessary to "reduce or eliminate the hazards of unprotected lead wires and patient cables."