In a Federal Register Notice published August 1, 2011 [Docket No. FDA-2011-N-0542], FDA set the rates for medical device user fees. The rates include a standard fee and a fee for small business. A company with no more than $100 million in sales in the most recent tax year may qualify for the reduced small business fee. A business with gross sales of no more than $30 million may also qualify for a waiver of the fee for the first premarket application (PMA, PDP, or BLA) or premarket report.
The table below shows the FY 2012 fee schedule.
|Application fee type||Standard fee||Small business fee|
|Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262))||$220,050||$55,013|
|Premarket report (submitted under section 515(c)(2) of the FD&C Act).||$220,050||$55,013|
|Efficacy supplement (to an approved BLA under section 351 of the PHS Act).||$220,050||$55,013|
|510(k) premarket notification submission||$4,049||$2,024|
|513(g) (21 U.S.C. 360c(g)) request for classification information.||$2,971||$1,485|