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FDA/MDUFMA | GPOs | Reimbursement | Gainsharing | Int'l | Sm. Bus. | Patent | Other

2004 MDUFMA Updates

FY 2005 MDUFMA Small Business Qualification Worksheet and Certification
On Thursday, August 12, 2004, the FDA published a guidance document concerning the small business qualifications and certification process under MDUFMA for FY05.  Companies with less than $30 million in annual revenue (including affiliates) may qualify for reduced fees.
Guidance for Industry and FDA

MDMA Continues to Call for Legislative Modifications to Stabilize Skyrocketing FDA User Fees
For the second straight year, the Food and Drug Administration has dramatically increased the user fees for reviewing medical technologies. The new rates, associated with the Medical Device User Fee and Modernization Act (MDUFMA), were published August 2, 2004, in the Federal Register and take effect October 1, 2004. 
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PRESS RELEASE
Federal Register Notice

Daniel G. Schultz, MD, Named Director of FDA's Center for Devices and Radiological Health
On July 20, 2004, FDA Acting Commissioner Dr. Lester Crawford announced that Dr. Dan Schultz will become the permanent Director of the Center for Devices and Radiological Health (CDRH).  Dr. Schultz has served as Acting Director since Dr. David Feigal’s departure on April 1. Prior to that role, Dr. Schultz was the Director of the Office of Device Evaluation (ODE).

MDMA has enjoyed a longstanding and productive relationship with Dr. Schultz and we look forward to working with him on a variety of issues including MDUFMA.
Click here to view FDA's press release

FDA Announces FY05 User Fee Rates
On July 15, 2004, representatives from MDMA met with officials from FDA to discuss the FY05 user fee rates. Unfortunately, the news was not good. For the second year in a row, FDA is predicting a significant revenue shortfall from user fees.  Based on a straight line projection for the last 3 months of the fiscal year, the shortfall is estimated to be $5.2 million for FY04. In addition, FDA has lowered the estimated number of fee generating submissions they expect to receive from FY05-FY07 without lowering the revenue totals. As a result, industry will be forced to pay more per submission.
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