The number of field agents in the Food & Drug Administration’s Center for Devices and Radiological Health plunged, even as the number of adverse events reported to the agency climbed, according to a report by the ProPublica website.
Between 2006 and 2007, the number of adverse events reported to the FDA involving medical devices jumped by 30,000 — a 30 percent spike. The number of CDRH field agents between 1997 and 2007, meanwhile, went from 577 to 401 — a 30 percent decline:
Number of Full-Time Employees in the Food and Drug Administration’s Medical Devices Field Division
Number of Adverse Events Reports to the FDA By Device Manufacturers
The numbers below are the summation of the reports submitted by device manufacturers that have been classified as having an “event type” of injury, death, or malfunction.