FDA Gives $9.5 Million Back to Industry in User Fee Relief Medical device firms are going to have

FDA Gives $9.5 Million Back to Industry in User Fee Relief

Medical device firms are going to have a little more money in their coffers next year, courtesy of the U.S. Food and Drug Administration (FDA). The agency recently informed companies that it is cutting user fees by about 7 percent in 2012, when the Medical Device User Fee and Modernization Act is up for renewal. Considering the tension and restless (yet slow-moving) negotiating between the device industry and the FDA, a reduction in user fees might be viewed as a small victory for device firms.

According to documents released by the agency, the annual user fee for medical device companies will be $2,029 in 2012, compared with $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 this year. For premarket applications, companies will have to pay $220,050 per submission, compared with $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 businesses will pay $55,013 in 2012, compared with 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 expected 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 II—about $8.5 million of that total is classified as unearned revenue, leaving $9.5 million to go back to the industry in the form of user fees.