FDA to collect 2014 user fees with end of shutdown

10/17/2013 | MassDevice.com (Boston)

Because the government shutdown is over, the FDA can start collecting fiscal 2014 user fees from medical device-makers, which include an overall increase of 4.2% from the previous year. Applications for 510(k) clearances are now $2,585 for small businesses and $5,170 for large companies, while premarket approval applications now cost $64,630 for small businesses and $258,520 for large corporations. The new rates went into effect Oct. 1.

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MassDevice.com (Boston)

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