For fiscal year 2003 (October 1, 2002 through September 30, 2003), the following fees will apply:
| Table 1 — FY 2003 Device Review User Fees | | Application | Standard Fee | Small Business | | Premarket application (PMA, PDP, BLA) | $154,000 | $58,520 | | Premarket report (premarket approval application for a reprocessed device) | $154,000 | $58,520 | | Panel-track supplement | $154,000 | $58,520 | | Efficacy supplement | $154,000 | $58,520 | | 180-day supplement | $33,100 | $12,582 | | Real-time supplement | $11,088 | $4,213 | | 510(k) | $2,187 | *$2,187 |
*For FY 2003, all 510(k)s are subject to the standard fee of $2,187. The law provides for a reduced 510(k) fee for a small business in FY 2004 and later years. FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year. | 
