FDA Lists Most Common Entry Errors for Medical Devices
The Food and Drug Administration recently posted a list of the most common entry errors for imports of medical devices. From October 2016 through March 2017, 45 percent of all validation errors detected by FDA’s PREDICT system were caused by…
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the firm name on the entry not matching the firm name on file for the listing number transmitted, followed by the registration number on the entry not matching the registration number for the listing number, at 18.3 percent. Another common error was no registration number transmitted for the foreign manufacturer or device exporter, at 7.8 percent, FDA said.