FDA Sets FY 2012 Medical Device Fees

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
Panel-track supplement $165,038 $41,259
180-day supplement $33,008 $8,252
Real-time supplement $15,404 $3,851
510(k) premarket notification submission $4,049 $2,024
30-day notice $3,521 $1,760
513(g) (21 U.S.C. 360c(g)) request for classification information. $2,971 $1,485