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CDRH Official Links Reorg To Drop In Warning Letter Count

 
• By Elizabeth Orr

Far fewer warning letters are being issued by the US FDA’s device center than in previous years. A center compliance official said that in addition to changes in enforcement practices, the drop was also influenced by CDRH’s recent move to centralize device review staff in the so-called “super-office.”

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The recent “super office” reorganization in the US Food and Drug Administration’s Center for Devices and Radiological Health has contributed to a drop in the number of warning letters issued over the past two years, according to an FDA official.

Erin Keith, CDRH’s associate director for compliance and quality, spoke as part of an FDA compliance panel at the Food...

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