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FDA releases medical device user fees for 2013

Tue, 07/31/2012 - 1:23pm
Mass Device

The FDA releases the pricing structures for medical device review pathways for 2013, as prescribed in the 3rd iteration of the Medical Device User Fee Act.

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The FDA this week released the 2013 pricing structure for medical device review, including discounted pricing for companies with less than $100 million in annual revenues.

The fees, which represent as substantial increase from rates for 2012, were established in the 3rd iteration of the Medical Device User Fee Act agreed upon by the med-tech industry and the federal watchdog agency.

MDUFA III nearly doubles total user fees for medical device companies from $295 million over 5 years to $595 million - but the industry expects something in return.

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