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Written by Richard R. Oswald
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Tuesday, 29 January 2008 |
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Reported in the Wall Street Journal today is the following paragraph on FDA inspections of foreign manufactured medical devices;
"In testimony scheduled to be delivered today before a House Energy and
Commerce subcommittee, the Government Accountability Office will tell
lawmakers that it found "weaknesses" in the agency's oversight of an
industry that makes products ranging from contact lenses to
defibrillators. According to FDA officials' own estimates, overseas
makers of the riskiest products, such as pacemakers, were examined only
every six years, and moderate-risk device manufacturers on average went
an estimated 27 years between FDA inspections."
27 years? No wonder manufacturers flock to foreign factories.
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