One person characterized the proposed new version of MDUFMA
(referred to as "MDUFMA
II") and its service standard this way:
Limited available data indicate that FDA has been meeting some MDUFMA
performance goals established for fiscal year 2005.
II also establishes new fees for two types of application submissions.
Since 2003, all user fee revenues under MDUFMA
have been strictly tied to premarket submissions, including PMAs, 510(k)s, some biologic license applications, and various supplements, and are paid by firms at the time of the submission.
FDA had limited data that could be used to measure the agency's performance against most of the MDUFMA
While there may be a spending trigger in FDA's preferred version of a MDUFMA
Along with congressionally appropriated funds, MDUFMA
reauthorization will provide the agency with revenue of $287 million by October 2012, according to FDA officials.
Device center staffers have emphasized that the center is on track to meet the fiscal year 2006 MDUFMA
targets for review of PMA and 510(k) submissions and is gearing up to meet the more stringent FY 2007 goals.
The objective in reauthorizing MDUFMA
was to set user fees at cost levels that would stabilize the device review program financially, while also improving the device pre-market review process.
However, other bills and draft bills are being considered in Washington that also will have a direct impact on the medical technology industry and may be included in legislation reauthorizing PDUFA and MDUFMA
FDA should work to improve the process by which companies and the agency negotiate clinical trial designs, several participants argued at the third annual MDUFMA
stakeholder meeting Nov.
According to the FDA, the latest iteration of MDUFMA
--often called MDUFMA
ll-will provide the industry with more predictable and stable fees, set new timelines for the evaluation process and help encourage greater transparency.