The other alternative is too many deaths, right?  If manufacturing is done over seas and outsourced, then to ensure safety there's no other way around it...when you don't keep up with technology and move along with everyone else, it will catch up..BD 

“The FDA has not kept up with the globalization of the industry it regulates,” said Marcia Crosse, director of health issues at the Government Accountability Office.

A GAO report released last week found a growing backlog of medical device inspections. The FDA inspects domestic manufacturers of high-risk devices, like pacemakers, once every three years; medium-risk devices, including syringes and hearing aids, every five.

Inspections of foreign manufacturers occur even less frequently: six years for high-risk devices, and 27 years for medium-risk.

FederalTimes.com

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