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Medical device companies more frequently investigated under Obama

The Hill, May 14, 2013

Federal regulators issued the highest amount warning letters to medical device companies in 2012 than over the last seven years, according to a new study. Emergo Group, a worldwide medical device regulatory compliance firm, says the Food and Drug Administration's (FDA) more rigorous – and more frequent – inspections during the Obama administration have resulted in the uptick in citations. The inspections hit a seven-year low in 2008 – with 1,423 investigations – and have increased ever since, reaching 2,121 by 2011 and dipping slightly last year to just more than 2,000. Accordingly, there were 74 warning letters issued in 2007, an eight-year low – with an increase to 98 in the slow investigation period in 2008 – and have grown exponentially each year to 164 in 2012.