Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this.

There just aren’t enough FDA inspectors to do the job—not by a long shot. Consider that in 2012, the FDA’s most active inspection year in history, only five percent of overseas manufacturers registered to sell in the United States were inspected. This is one-tenth the number of foreign inspections that needs to be done each year, but the FDA simply can’t do it. The FDA has tried using third-party audits for the inspections but the “third party” has always been and continues to be set up as a voluntary system—and these voluntary programs fail. Yet, here we go again.

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