5/15/2013

The more frequent and thorough inspections conducted by the FDA under the administration of President Barack Obama have led to an increase in warning letters issued to medical-device makers, according to a study from Emergo Group. The FDA issued more warning letters to medical-device makers in 2012 than in the previous seven years, the study found. "Medical device firms should expect the trend of stepped-up FDA inspections to continue through the Obama administration's second term," Emergo Group said.

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