62 Food and Drug Law Journal 581-592 (2007).
As part of FDA’s Medical Device Postmarket 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.
This paper was undertaken to compile and analyze the publicly available data to make it easier for the reader to get an overview of the content of Class I recalls over a recent three fiscal year period (2004-2006). Recalls were analyzed based on available information, including total number of units recalled, reasons for recalls, or medical device classification. The goal of this analysis was to distill the voluminous information made publicly available by FDA into a series of “snapshots” for use by the multidisciplinary medical device community in general. Because of the wide utility of this data, this article will not draw conclusions specific to areas of law, business or engineering. Rather, it is intended for the readers to make use of this summary of information to best suit their needs as related to their involvement within the medical device community, whether it is from the legal, business or engineering perspective.