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.