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 |