On September 27, 2007, the President signed an act reauthorizing medical device user fees for fiscal years 2008 - 2012. The legislation — the Medical Device User Fee Amendments of 2007 — is part of a larger bill — the Food and Drug Administration Amendments Act of 2007 (H.R. 3850) — that affects many other FDA programs.
FDA will provide additional information concerning the 2007 Amendments during the coming weeks. Please check this site periodically to learn more. Here are some of the key changes you should be aware of —
All existing application fees will be substantially reduced for FY 2008, and small business discounts are even more generous:
How Will the 2007 Amendments Affect Existing Fees? |
||||||
Existing Fees for FY 2007 |
New Fees for FY 2008 |
Percentage Reduction from FY 2007 to FY 2008 | ||||
---|---|---|---|---|---|---|
Application Type | Standard Fee |
Small Business |
Standard Fee |
Small Business |
Standard Fee |
Small Business |
Premarket Application (PMA, PDP, PMR, BLA) |
$ 281,600 | $ 107,008 | $ 185,000 | $ 46,250 | -34% | -57% |
Panel-track PMA Supplement | $ 281,600 | $ 107,008 | $ 138,750 | $ 34,688 | -51% | -68% |
BLA Efficacy Supplement | $ 281,600 | $ 107,008 | $ 185,000 | $ 46,250 | -34% | -57% |
180-day PMA Supplement | $ 60,544 | $ 23,007 | $ 27,750 | $ 6,938 | -54% | -70% |
Real-time PMA Supplement | $ 20,275 | $ 7,705 | $ 12,950 | $ 3,237 | -36% | -58% |
510(k) Premarket Notification | $ 4,158 | $ 3,326 | $ 3,404 | $ 1,702 | -18% | -49% |
In conjunction with substantially reducing existing application fees, the 2007 Amendments provide for new types of medical device user fees —
The new fees for FY 2008 are summarized in the following table:
New Types of Fees | ||
FY 2008 | ||
---|---|---|
Application Type | Standard Fee |
Small Business |
30-day Notice | $ 2,960 | $ 1,480 |
513(g) Request | $ 2,498 | $ 1,249 |
Periodic Reporting on a Class III Device |
$ 6,475 | $ 1,619 |
Establishment Registration | $1,706 |
As soon as possible, FDA intends to provide updated guidance on how your business can qualify as a “small business” for FY 2008. The new guidance will be announced on this web page as soon as it is available. If you qualify as a small business for FY 2008, you will be able to pay any FY 2008 fee as the discounted small business rate. You may also be able to receive a waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report).
The 2007 Amendments provide a means for a foreign business to qualify as a “small business,” even if it cannot provide a Federal (U.S.) income tax return. The foreign business will have to provide certain information to FDA, including a “National Taxing Authority Certification” from the local equivalent of the U.S. Internal Revenue Service. As soon as possible, FDA intends to provide updated guidance on how your business can qualify as a “small business” for FY 2008. The new guidance will be announced on this web page as soon as it is available.
Updated September 28, 2007
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