Medical Device Recalls from 2004 to 2006: A Focus on Class I Recalls

摘要

As part of the Food and Drug Administration's (FDA's) Medical Device Post-market Transformation Initiative, the Center for Devices and Radiological Health (CDRH) is taking steps to increase its ability to identify, analyze and act on postmarket information in order to improve the safety and effectiveness of medical devices. Over the past few years, the media has focused on a number of medical device recalls leading to even more attention and awareness by the general public. It is evident that medical device recalls have gained more attention from regulatory, manufacturing, engineering, clinical and human factors standpoints.