A recent report by Greenleaf Health consultancy indicates that the Center for Devices and Radiological Health (CDRH) has increased enforcement activity compared to previous years per an article on mddionline.com. The report, led my former FDA associate commissioner for regulatory affairs, Michael Chappell, focuses on four specific areas of medical device enforcement data: FDA inspections, FDA Form-483 observations, warning letters and product recalls. The report found nearly a 40% increase in CDRH inspections since 2008 and more than 250% increase in device recalls since 2007. These findings may be the result of the FDA commissioner, Margaret Hamburg ordering a more thorough agency-wide effort on compliance and enforcement. To purchase Greenleaf Health’s full report, click here. To read a free abbreviated report, click here.
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