FDA and AdvaMed today made public the agreement that should form the basis for the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA). The new user fee scheme will promote a 6.4% increase each year between FY 2008 and FY 2013. It significantly reduces application fees but adds two new fees. The details can be found in a notice of a public meeting to be held on April 30 for discussion of the topic. As expected, MDUFMA II eliminates the adjustments that made the year-to-year use fee increases so volatile. Instead, to promote more consistent funding, the proposal recommends two new fees that wouldn'tÂ change much from year to year and wouldÂ generate about 50% of total fee revenue. They are an annual establishment registration fee and an annual fee for filing periodic reports. The annual establishment fee would in FY 2008 be $1706 per device manufacturer, single-use reprocessor, and specification developer. A firm would not be considered legally registered without paying this fee. It is expected to generate around $21.8 million in FY 2008. The periodic-report fee would start at $6,475 in FY 2008 and, assuming 425 devices are subject to it and most don't qualify for the small-business rate, would generate about $2.5Â million in FY '08. These allow application fees to be reduced. PMA fees would be $185,000 in FY 2008, a 34% reduction from this year. Panel-track supplement fees would be reduced 51%, 180-day PMA supplement fees by 54%, real-time supplement fees by 36%, and 510(k) fees by 18%. However, there would now be fees for 30-day notifications and 513(g) classification requests, which are free currently. The small-business discount, for firms with less than $100 million in annual revenues, remains in effect. CDRH's performance goals have been modified to focus on the time it takes to make a final decision, rather than interim goals. Significantly, the goals include for the center to make decisions on 50% of PMAs, panel-track supplements, and premarket reports within 180 days, and 90% within 320 days. Congress will now take up the matter, and will likely combine it with a measure to reauthorize pharmaceutical user fees. The Senate is expected to start tackling it on Wednesday. AdvaMed is happy with the agreement -- read its press release to see for yourself.Â Same for FDA.
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