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Most changes to MDUFMA were made to speed up approval and clearance times for devices, partly by raising fees paid to the FDA (to which the industry did not balk, provided that speed and predictability from the agency are forthcoming).
One person characterized the proposed new version of MDUFMA (referred to as "MDUFMA II") and its service standard this way: A quick review with inadequate safeguards harms patients.
Limited available data indicate that FDA has been meeting some MDUFMA performance goals established for fiscal year 2005.
MDUFMA 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 performance goals.
"While there may be a spending trigger in FDA's preferred version of a MDUFMA agreement.
Despite talk of "bipartisan consensus," some points during negotiations for MDUFMA II (as the most recent iteration of the user fee program often is called) were politics as usual in Washington.
Acting FDA Commissioner Andrew von Eschenbach said the agency needs to go beyond the "incremental" improvements it has made in speeding up the review of device premarket applications under the Medical Device User Fee & Modernization Act (MDUFMA).
The stage is set for Congress to reauthorize the latest version of the Medical Device User Fee and Modernization Act (MDUFMA II), which is scheduled to sunset on Oct.
Schultz has previously suggested that CDRH might be interested in applying user lee funds, currently reserved mostly for premarket review activities, to postmarket surveillance under a revised MDUFMA law.
Legislation to reauthorize the Medical Device User Fee and Modernization Act (MDUFMA) is on its way to a vote in the Senate.
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