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.
FDA had limited data that could be used to measure the agency's performance against most of the MDUFMA
Along with congressionally appropriated funds, MDUFMA
reauthorization will provide the agency with revenue of $287 million by October 2012, according to FDA officials.
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.
fees follow suit, the application fee for a PMA will climb to $871,000 within 12 years, and 510(k) fees will escalate to $12,500.
In addition to the possibility of the pediatrics bill being attached to the reauthorization of MDUFMA
and/or PDUFA, speculation exists that the Enhancing Drug Safety and Innovation Act would be tied to this vehicle as well.
It was only because of MDMA that smaller, entrepreneurial firms were even considered in the MDUFMA
legislation," Touhey said, and "it was only because of reassurances made us by Congress and FDA that the agency would fulfill its end of the bargain that we supported the bill.
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.
MTC), (OTCBB:MDSC) of Cherry Hill, New Jersey, a developer of imaging technology for molecular detection of cancer and physiological change, announced: on December 11, 2003 the FDA, after review, qualified the Company under MDUFMA
(The Medical Device User Fee and Modernization Act of 2002) allowing both reduced or waived FDA fees for its 2004 medical device 510K market approval submissions.
Originally passed four years ago, the MDUFMA
was amended in 2005 and is up for renewal by the end of September this year.
Our session at MD&M West will present an overview of MDUFMA
, which includes a summary that is intended to describe three key provisions of the new law: 1) user fees for pre-market reviews; 2) establishment inspections by accredited third parties; and 3) new regulatory requirement for reprocessed single use devices.