08.05.11
Maybe things are starting to look up: after paying an excess amount of user fees in 2011, medical device companies were informed this week that the U.S. Food and Drug Administration (FDA) is cutting user fees by about 7 percent in 2012, when the current medical device user fee act is set to expire. Considering the tension and restless (yet slow-moving) negotiating between the device industry and the FDA, a relief in user fees might be viewed a small victory for those on the device side.
According to documents released by the agency, the annual user fee for medical device companies will be $2,029 in 2012, compared to $2,179 in 2011. Any company wishing to market a medical device in the United States must pay the fee, regardless of size.
Companies will be required to pay $4,049 per 510(k) premarket submission, compared with the $4,348 they paid in 2011. For premarket applications, companies will pay $220,050 per submission, compared to $236,298 last year.
A small business discount will be applied for companies with less than $100 million in annual sales, making their new total for 510(k) premarket submissions $2,024 in 2012, compared with $2,174. For premarket applications, small business will pay $55,013 in 2012, compared to the $59,075 they paid in 2011.
Finally, companies with less than $30 million in sales qualify for a waiver of the first PMA (premarket approval) fee.
The total amount of money collected by the FDA in user fees in 2011 is anticipated to be more than $18 million higher than the $61.8 million appropriated to the agency by the Medical Device User Fee and Modernization Act (MDUFMA) II—about $8.5 million of that is classified as unearned revenue, leaving $9.5 million to go back to the industry in the form of user fees.
According to documents released by the agency, the annual user fee for medical device companies will be $2,029 in 2012, compared to $2,179 in 2011. Any company wishing to market a medical device in the United States must pay the fee, regardless of size.
A small business discount will be applied for companies with less than $100 million in annual sales, making their new total for 510(k) premarket submissions $2,024 in 2012, compared with $2,174. For premarket applications, small business will pay $55,013 in 2012, compared to the $59,075 they paid in 2011.
Finally, companies with less than $30 million in sales qualify for a waiver of the first PMA (premarket approval) fee.
The total amount of money collected by the FDA in user fees in 2011 is anticipated to be more than $18 million higher than the $61.8 million appropriated to the agency by the Medical Device User Fee and Modernization Act (MDUFMA) II—about $8.5 million of that is classified as unearned revenue, leaving $9.5 million to go back to the industry in the form of user fees.