With the explosive growth in imported goods to the United States, what is the Food and Drug Administration (FDA) doing toward maintaining a level of service inspection that ensures the best protection of the public health? One option is to partner with the countries exporting the supplies. Perhaps a less obvious option is for the FDA to demand of itself the same level of regulatory compliance and reporting that it requires of the medical device industry and other industry segments.

As the FDA pushes even harder on the medical device and life sciences industries toward electronic reporting to the administration, the FDA must rise to the challenge of handling the increasing volume of electronic medical device reports (eMDR) and other electronic submissions while facing more budget cuts.

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