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FY 2003 Device Review User Fees
President George W. Bush Oct. 26 signed into law a bill that requires manufacturers to pay the U.S. Food and Drug Administration a fee in exchange for faster review times.
Following is a list of the fees that apply until Sept. 30, 2003.
| 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 | N/A FY 2003* |
| The FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. The FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year. | ||
| *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. Source: fda.gov |
||
For breaking news, go to www.homecaremonday.com, the electronic news service of the home medical equipment industry.
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© 2008 Penton Media Inc.
