FDA Updates List of Medical Devices Subject to Tracking Requirements
April 2, 2014 | Risk Management News
The U.S. Food and Drug Administration (FDA) has revised its list of devices subject to medical device tracking requirements to provide more specificity about the tracked devices and to remove three types of medical devices from tracking requirements, according to March 27, 2014, guidance posted on FDA's website. The updated guidance identifies all affected devices (those tracked and those released from tracking) in table format. The table includes two fields to describe each device: (1) product code (procode) and (2) the standardized procode definition (product code – preferred term). These two descriptive fields are intended to provide clarity about which devices are tracked. For example, instead of listing a "direct-current defibrillator" as a tracked device, the agency lists three types of automated external defibrillators and two types of manual defibrillators.