By: Ellyn McMullin, Research Associate
The Agency Continues to Take Measures to Ensure the Safety and Quality of Imported Medical Devices
Five years ago FDA unveiled its new global strategy to help ensure safety and quality of imported products in an increasingly complex global supply chain. According to the agency, in 2011 half of all medical devices used in the United States were imported, while 80% of the active pharmaceutical ingredients in medications sold here were manufactured elsewhere. It was optimistically estimated that imports of FDA-regulated products would triple between 2007 and 2015; of course, with the severe recession, the results did not quite reach that projection. However, the increase in imports was still significant.
A key component of the FDA’s new approach (as detailed in a special report “Pathway to Global Product Safety and Quality”) was to partner with its counterparts worldwide to insure and improve global product safety and quality. As reported in 2014, the FDA had at that time more than 60 agreements with their counterparts to share some information in inspection reports.
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