Aug 2, 2011

The US Food and Drug Administration will reduce medical device user fee rates for its 2012 fiscal year, due to $9.5 million in excess appropriations from 2011. The new rates have been published as US legislators and industry lobbying groups are aggressively questioning FDA arguments for fee increases when the Medical Device User Fee and Modernization Act comes up for renewal next year.

The agency has decided that the excess funds it collected in 2011 under the Medical Device User Fee Amendments of 2007 should be returned to device manufacturers and sponsors in the form of reduced 2012 fees rather than used to reform premarket review processes, according to

The FDA’s 2012 fiscal year begins October 1, 2011. Fees set for 2012 include:

  • Standard premarket application (PMA) fees of $220,050 and small business PMA fees of $55,013, down from $236,298 and $59,075 respectively in 2011
  • Standard 510(k) submission fees of $4,049 and small business 510(k) fees of $2,024 compared to $4,348 and $2,174 respectively in 2011
  • Annual establishment registration fees of $2,029, down from $2,179 last fiscal year


Manufacturers with less than $100 million in sales for their most recent tax years qualify for small business fees; firms that qualified for this reduction in 2011 will have to re-qualify for the 2012 fiscal year. Furthermore, firms with less than $30 million in sales may also qualify to have fees waived for their first PMA submissions or premarket reports.



  • Stewart Eisenhart