FDA Medical Device Inspections No Where Near Adequate
January 29th, 2008 joshua
The Food and Drug Administration is lax in its inspection of medical device makers, both foreign and domestic, a government investigator told Bloomberg News.
The FDA aims to inspect U.S. manufacturers of high-risk medical devices like heart defibrillators every two years. However, inspections are only conducted every three years and that figure jumps to six years for foreign makers.
A House subcommittee is currently investigating these findings and will learn that funding needs to keep up with scientific advancements and until these equal, American lives are at risk, the report says.
The House will hear about inspections on device and drug makers and is likely to hear the same that it did in November of last year. Then, the House learned that only seven percent of these foreign companies are inspected annually. At that rate, it would take 13 years to inspect all the companies, leaving far too long of a time between inspections.
The numbers get worse for inspections of makers of medium-risk devices, such as hearing aids, the report found. A company making these devices domestically only gets inspected every five years and foreign makers are inspected every 27 years and many have never been inspected by the FDA.
