TESTING METHODOLOGIES IN SHARPS SAFETY DEVICE GUIDANCE NEE; REEVALUATION
This article was originally published in The Gray Sheet
Executive Summary
TESTING METHODOLOGIES IN SHARPS SAFETY DEVICE GUIDANCE NEE; REEVALUATION by an expert committee, FDA's General Hospital and Personal Use Devices Panel suggested at a meeting May 11. The panel recommended that the 510(k) guidance on sharps devices with injury prevention features remain as a draft until the expert committee can provide input.