2005 MDUFMA Updates
MDMA Addresses Attendees at FDA's 3rd Annual MDUFMA Stakeholder Meeting
November 17, 2005 -- MDMA addressed attendees at FDA’s 3rd Annual MDUFMA Stakeholder Meeting in Gaithersburg, MD. MDMA expressed its concern regarding the lack of data related to FDA’s resource needs and how FDA was currently using user-fee revenues. In addition, MDMA Executive Director Mark Leahey reiterated the need for a reasonable and rational user-fee system along with revised FDA performance goals to ensure that patients have access to safe and effective products in a timely manner. MDMA said that modifications to the program are needed in order for the association to support MDUFMA reauthorization.
Click on the links below to view both slide presentations presented at the meeting.
"Premarket Review Performance Goals" 
"The User Fee Structure"
MDUFMA FY06 Fee Rates and Small Business Certification
The FDA announced the FY06 user fees that will take effect on October 1, 2005. Due to the recent legislative modifications, companies with a reported gross receipts or sales of no more than $100 million on their Federal income tax return for the most recent tax year can qualify for the small business fee discounts.
To review the Small Business Certification Worksheet and submit an FY 2006 MDUFMA Small Business Qualification Certification Form (FDA 3602 for FY06) please click on the link below. You must have a Small Business Decision number from FDA to receive a fee discount.
Click here for more details.
President Signs MDUFSA into Law
August 1, 2005 - President Bush signed into law H.R. 3423, the "Medical Device User Fee Stabilization Act of 2005" (MDUFSA), which amends the user fee system established by the Medical Device User Fee and Modernization Act of 2002.
MDMA praised President Bush for enacting this important legislation which will help ensure that patients have timely access to safe and effective medical technologies. "MDUFSA provides much needed fee relief for smaller companies who are the engine driving innovation in the medical technology industry. MDMA looks forward to working with FDA, Congress and the industry to make sure this program works as intended" stated MDMA Executive Director, Mark Leahey.
MDMA Praises Congress for MDUFSA Passage
July 28, 2005 - The Medical Device Manufacturers Association (MDMA) applauds action taken by Congress to ensure that patients have timely access to safe and effective medical technologies. “The Medical Device User Fee Stabilization Act of 2005” increases the threshold for granting small business relief from $30 million to $100 million, stabilizes fee increases at 8.5% and requires reprocessors to label single use devices.
To read this week’s Washington Times article about MDUFSA and MDMA click here.
To learn more about the MDUFSA negotiations click here.
MDMA Applauds Senate HELP Committee's Vote on MDUFMA Bill
July 20, 2005 - The Medical Device Manufacturers Association (MDMA) today welcomed action by a Senate Committee to help smaller medical technology innovator companies afford the rising costs of device submission fees for important new products.
The Senate Health, Education, Labor and Pensions Committee unanimously passed out of committee the Medical Device User Fee Stabilization Act of 2005.” This bill, among other provisions, increases the threshold for granting small business relief from $30 million to $100 million for device submissions.
To read MDMA's press release click here.
MDUFMA Alert
MDMA Applauds Crawford's Senate Confirmation as Commissioner of the FDA
July 18, 2005 - The Senate confirmed by a vote of 78-16 Lester M. Crawford to serve as the Commissioner of the Food and Drug Administration (FDA). Dr. Crawford was nominated by the Bush Administration this spring to head the Agency and the Senate HELP committee approved the nomination on June 15th.
MDMA praised the Senate vote and expressed confidence in the President’s selection for FDA Commissioner. Dr. Crawford’s experience and leadership will allow him to deal with the challenges associated with the rapid innovation in the medical technology industry. MDMA looks forward to continuing to work with Dr. Crawford on a variety of issues important to patients and innovators” MDMA Executive Director, Mark Leahey stated.
MDMA Chair and CEO of Percardia, Nancy Briefs, also expressed support for Dr. Crawford. “MDMA congratulates Dr. Crawford on his confirmation. His leadership and ability will ensure that patients have timely access to safe and effective medical technologies.”
MDMA Applauds Bush Administration's Nomination of Dr. Lester Crawford to Head FDA
February 15, 2005 - MDMA applauds President Bush’s nomination of Lester M. Crawford, DVM, PhD, as Commissioner of the Food and Drug Administration. Crawford has been serving as the Acting FDA Commissioner since March 2004 when former FDA Commissioner, Dr. Mark McClellan, left the agency to head the Centers for Medicare and Medicaid Services. Prior to his service at FDA, Crawford was Chairman of the Department of Physiology-Pharmacology at the University of Georgia, and Administrator of the Food Safety and Inspection Service at the Department of Agriculture. MDMA looks forward to working with Dr. Crawford this year as Congress, the FDA and the industry seek to ensure the effectiveness and sustainability of the medical device user fee program. His knowledge of the medical technology industry and his experience will help guide the FDA in its pursuit to advance the nation’s public health.
CDRH MDUFMA Quarterly Report
On January 27th, MDMA met with the FDA’s Center for Devices and Radiological Health (CDRH) and other industry representatives regarding FDA’s cost report, which is being prepared by Dr. Dale Geiger. Dr. Geiger cautioned the group that there are problems with accessing certain data critical to the study i.e. the labor data quality is not sufficient to differentiate original, modular, expedited, panel track and HDE PMA’s and that the labor reporting system aggregates all PMA supplement efforts into one reporting code, therefore it was going to be impossible to disaggregate for 180 day, real times and manufacturing supplements. The results of this study should be released in July, but MDMA will be meeting with Dr. Geiger in April to discuss further progress on the report. FDA reviewed performance goals stating that they have been meeting or exceeding the goals. In addition, FDA talked about staffing increases at CDRH and preliminary results for the 1st Quarter showed $7.6 million in user fee revenues. MDMA concluded the meeting by re-emphasizing our position on the need to stabilize fees by allowing only for an increase in inflation, having the industry’s $4 million shortfall be forgiven and for FDA to continue analyzing the performance goals and enhance those goals where necessary.
View CDRH presentation