Note: FDA's Fiscal Year 2008 started on October 01, 2007| Site Map | Home Page | InVitro Diagnostics | Health and WellBeing | Combination Products |
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Note: FDA's Fiscal Year 2008 started on October 01, 2007
MeddiQuest's Neil R. Armstrong looks at the background and reviews the changes to the US Food and Drug Administration's Medical Device User Fees for the Fiscal Year 2008.
It is a fact of the American political system that whenever the US Congress and President are opposed, it is the finance bills that suffer - and they usually end up in a stand-off. So it was with this year's modernization act, which renewed User Fees for the new fiscal year. Finally signed into law at the end of the last week of September, it became live the next Monday, October the first.
As always with any contentious bill, there was a bit of last minute horse trading and so the outcome was not exactly what anybody wanted ... or expected! Hence there has been a bit of rapid catching up to do on the part of FDA!
While many of the existing user fees have been reduced, new fees have been introduced for submissions that were previously free of charge, but, most significantly for many small international customers, the small manufacturer reductions in fees have been extended to non-US companies. However, there is a trade-off, and the singeing over USD 1,700 fee for Establishment Registration (with no small manufacturer reduction) is certainly a real penalty for many small companies with an uncertain US market. It may sound a small price to pay for entry to the largest medical device market in the world and 40 per cent by value of the global devices market, but it can take many years to build a significant US market and this will be a real deterrent to many.
| FY2007 Fees | FY2008 Fees | 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% |
| 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 | |
International manufacturers can now apply for these, but the process is a little complex. First the company has to apply to FDA with a government-certified tax return or statement showing a sales volume less than USD 100M or equivalent, FDA warns that it may take 60 days to consider such applications. Only then will the small business be able to use to certificate number to pay the small manufacturer rate through the User Fee system. Of course this is all based on the last tax return (or financial year of the manufacturer ... so apply too early or with an old tax document and you may fine the certificate is out of date by the time you want to claim the reduced user fee for your next submission ... there again leave it too late, and you might have another two months to wait!
So while nothing is simple, FDA have now issued their new guidance on claiming the small manufacturer discount, which includes a pdf form which can be filled in and printed out.
... and a last word of caution, if you are a small manufacturer about to submit and decide you can not wait another 60 days and will pay the full fee, there is a question in the User Fee Cover Sheet process which asks you to confirm you are not a small manufacturer (not a registered small manufacturer). If you say yes and then apply in the same year for a certificate, it appears to us that on one of the two occasions you will be giving FDA false information and at the very least could expect to have your request declined! We think this is just poor wording, not a deliberate move on the part of FDA ... maybe yet another clarification or change will follow!
When FDA put in the original request they thought it would generate USD 2.5M this year (FY 2008). Let's all remember these user fees are intended to provide FDA more resources to give a better service and be sure to let FDA know if we do not see a better service!
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