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.

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