2002-2003 MDUFMA Updates
2003
MDMA
Seeks FDA Commitment to Modify User Fee Review Program
On December 3,
2003, FDA's Center for Devices and Radiological Health (CDRH)
and its Center for Biologics Evaluation and Research (CBER)
held their First Annual Stakeholders Meeting relating to the
implementation of the Medical Device User Fee and Modernization
Act of 2002 (MDUFMA). MDMA Executive Director, Mark Leahey,
participated on panels discussing how the user fee process
is working one year into the program; electronic labeling
and Section 301; bundling, modular PMA and expedited applications;
third party inspections; and reuse. Paul Touhey, MDMA's immediate
past chairman and president of Fujirebio Diagnostics, Inc.,
also presented at the meeting.
PRESS
RELEASE
MDMA
Reacts to OMB Proposal
On October 29,
2003, the Bush Administration wrote to Congress outlining
funding levels for the Center for Devices and Radiological
Health (CDRH). Unfortunately, the request fell $38 million
short of the original agreement in the Medical Device User
Fee and Modernization Act of 2002 (MDUFMA).
PRESS RELEASE
MDMA
Concerned by Dramatic User Fee Increases
The Food and Drug
Administration recently published the FY04 device user fee
rates in the Federal Register. The new rates, associated with
the Medical Device User Fee and Modernization Act (MDUFMA),
take effect October 1, 2004. Fees for Pre-Market Approval
Applications (PMAs) and PMA supplements rose over 34 percent.
Original PMA fees increased from $154,000 to $206,811. Fees
for pre-market notifications [510(k)’s] jumped 59.1
percent for companies with sales over $30 million and 27.3
percent for companies with less than $30 million in sales.
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more…
2002
Medical
Device User Fee and Modernization Act
MDMA had a topic
call for members to discuss the Medical Device User Fee and
Modernization Act (MDUFMA) on Thursday, December 12, 2002.
Click a link below to view the participants’ presentations.
Note: Presentations
are in Microsoft Power Point format and require Internet Explorer
to view.
MDMA
MDUFMA Conference Call
John
Manthei - MDMA presentation
Harvey
Rudolph - MDMA presentation
Overview
of MDMA’s Position on the Medical Device User Fee and
Modernization Act
On October 26th,
President Bush signed the Medical Device User Fee and Modernization
Act of 2002. Both the House and Senate reached an agreement
regarding user fees the previous week.
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