Medical Devices

This FDA Medical Device Enforcement Report is going to surprise you. A lot.

Greenleaf Health LLC has issued a new report titled “FDA Medical Device Enforcement Report,” and some of the numbers in there are surprising to say the least.

Especially given the context of constant complaints from the medical device industry regarding its regulatory burden.

The Greenleaf Health executive summary paints a picture of the broader agency as the one cracking the enforcement whip, while the Center for Devices and Radiological Health seems quite evenhanded.


Consider the following data points:

  • Between 2005 and 2009, the number of warning letters that the U.S. Food and Drug Administration issued to errant companies remained fairly consistent. But that number jumped dramatically in 201o when it issued 673 warning letters, a 30 percent spike from 474 issued just the year before. And in 2011, the number was 1,720, more than double than in 2010. CDRH also issued more warning letters in 2011, but the number is much less eye-popping with less than 200 warning letters issued in 2011, compared with 152 in 2008. In fact, CDRH warning letters fell in 2011, compared with the number issued in 2010.
  • The same story repeats with the issuance of Form 483s. For FDA, the overall number was less than 4,000 in 2008 and by 2011, it had jumped to nearly 5,000. CDRH 483s, which comprise 6 percent of total FDA 483s, remained constant and hovered around the less than 1,000 mark.
  • When it comes to inspections, however, both FDA’s overall rate and CDRH’s rate have increased comparably between 2009 and 2011.
  • And a similar trend is noticed in recall numbers. In 2011, FDA recalled 9,288 products, more than double from the 4,266 products it recalled just five years ago. In 2011, 3,211 medical device products were recalled compared with 1,279 in 2007.
This is not to say that the specter of Form 483s and warning letters is not jarring, but the data seems to suggest that while there is an uptick in inspections, the result may not necessarily end with a slap on the wrist or worse.


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