Postmarket Surveillance
This article was originally published in SRA
Executive Summary
US FDA postmarket surveillance activities up in FY 2007
US FDA postmarket surveillance activities up in FY 2007
The number of device recall actions in the US in fiscal year 2007 increased slightly over the previous year, to 661 from 651. The recall actions for FY 2007 (1 October 2006 to 30 September 2007) involved 1,273 different products, the Food and Drug Administration said in its FY 2009 budget request1.
The FDA noted that it has successfully resolved significant enforcement actions against manufacturers involving medical device safety. In April 2007, the agency seized medical devices manufactured by Shelhigh for regulatory violations that “seriously compromised the sterility of the company's tissue-based devices used in surgical settings”. In June last year, pursuant to a court-ordered injunction, Shelhigh agreed to stop distributing its implantable devices until the company brought its production processes in line with FDA standards. In addition, GE OEC Medical Systems signed a consent decree of permanent injunction relating to its X-ray surgical imaging systems and agreed to ensure that the systems comply with FDA quality system regulations.
The FDA said that the postmarket safety area faces similar challenges to the premarket area, including ensuring product safety as the volume of medical devices increases. The increasing number of imports provides an additional challenge. The agency says it improved its risk-based targeting of inspection and import resources to help meet the new challenges. In 2007, its Office of Regulatory Affairs field force conducted more than 1,278 good manufacturing practice inspections in the devices area.
References
1. FDA Devices and Radiological Health budget request, www.fda.gov/oc/oms/ofm/budget/2009/Narratives/6_CDRH.pdf