Device tracking: user facility responsibilities.

Abstract

The purpose of FDA's device tracking regulations is to ensure that tracked devices can be traced from the device manufacturing facility to the person who receives the benefit of the device, that is, the patient. Although the manufacturer has the responsibility for establishing and monitoring the tracking program for their devices, the user facility has a key responsibility in assuring its success. The FDA initially identified 21 devices that require tracking and recently added two more to the list. This paper discusses the tracking system and the responsibilities of the manufacturer and the user facility. Information on each of the initial 21 devices to be tracked is presented, including device nomenclature, description, potential health risks, panel classification and regulation number, risk class, ECRI number, and references.