FDA CDRH Reports on Regulatory Activities

by Barbara Kram, Editor | August 14, 2006
Center of Devices and Radiological
Health releases 2005 annual report
The FDA's Center for Devices and Radiological Health has released its 2005 annual report.

Highlights include the agency's medical device post-market initiative. In FY 2005 CDRH overtook a comprehensive inventory of its postmarket safety programs, including recalls, MDR and MedSun (the surveillance reporting program by clinical facilities).

The postmarket safety program inventory considered how the Center identifies postmarket problems, assesses the information obtained, and responds to that information through both stakeholder communication and enforcement action. The Center's plan to strengthen its postmarket program focuses on: developing a "culture of collaboration" for postmarket safety within the Center; developing world-class data sources and systems to quickly and accurately collect, analyze, and disseminate information about potential risks; enhancing risk communication efforts; and improving coordination with the FDA field staff. A senior-level team, comprised of CDRH management and outside consultants experienced in medical device safety and product regulation will help guide the Center in this effort.

CDRH is developing an electronic adverse event reporting system that will facilitate processing the reports and reduce operating costs. In FY 2005 CDRH received, processed, analyzed and responded to about 180,000 medical device adverse events reported through CDRH's Medical Device Reporting (MDR) system. This system uncovered many public health issues and problems ranging from orthodontic headgear, hemodialysis systems and hospital beds, to cochlear implants, deep brain stimulators, and diagnostic tests for heart attacks and pregnancy.

Other topics of interest include CDRH's role in global harmonization, manufacturing oversight, radiation safety, and many other programs. Get highlights of the report at
http://www.fda.gov/cdrh/annual/fy2005/