MDUFMA First Quarter FY 04 Report (3/31/04)
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Introduction
The goals of MDUFMA give FDA the necessary start-up time to build infrastructure,
hire, and train staff, to be able to meet performance targets that generally
become applicable in 2005. As was the case with the Prescription Drug User
Fee Act ten years ago, the agency utilized the first year of MDUFMA to set
up the User Fee Program and establish necessary systems and procedures.
The long-term goal of MDUFMA is to provide FDA’s medical device program
with sufficient resources to ensure that safe and effective new products get
to consumers as quickly as possible. Enhanced staffing, increased training,
and better infrastructure will help FDA work more interactively and efficiently
with submitters to shorten development and review time for life saving medical
technologies by 2007.
During Fiscal Year 2004, for example, FDA expects to spend user fees to add
more than 100 additional staff, who will be fully trained and fully engaged
in the review process. These new staff members will conduct and support medical
device reviews, so that the agency can meet the challenging performance goals
associated with this program and ultimately help industry speed the development
and marketing of safe and effective new products.
MDUFMA established ten statutory deadlines in the first year, and FDA has
met all of them. Most of these requirements dealt directly with provisions
of the statute other than user fee performance goals. For example, during
the first year FDA
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established and staffed a new Office of Combination Products
to ensure the most efficient review of products that contain a device as
well as a drug or biologic component;
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ublished accreditation criteria, reviewed applications,
and accredited 15 third parties to perform inspections;
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published a list of reprocessed single-use devices that
will be subject to additional premarket requirements;
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published guidance for the submission of applications
for pediatric products and for protection of children during clinical trials
with medical devices.
FDA also published a number of additional guidances on a variety of the MDUFMA
provisions to train staff and help industry understand the agency’s
process for implementing MDUFMA, including the various user fee provisions.
A complete list of the guidances available, as well as other information about
MDUFMA implementation, can be found at www.fda.gov/cdrh/mdufma/index.html.
To provide feedback to the many parties with a stake in the success of MDUFMA,
including Members of Congress, FDA has several mechanisms to report on its
MDUFMA progress for Fiscal Year 2003.
The performance report being prepared for Congress will show that; while
there are some measures that indicate the agency is close to meeting some
of the statutory goals reiterated in the MDUFMA goals letter, the goals that
emphasize a complete review early in the process will require significant
improvement. This is particularly true with respect to breakthrough technologies,
or expedited review products, which is the area where the agency has committed
to the most significant changes.
Although performance in all areas has not changed dramatically during this
start up year, the agency has taken a number of steps that will contribute
to its ability to meet the aggressive goals that become effective in 2006
and 2007. In addition to establishing payment, billing, and small business
designation procedures for the user fee program, FDA has invested user fee
and appropriated dollars in a number of ways that will contribute to the ultimate
improvement in the review process in later years. Among other actions, CDRH
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has hired project managers for each product review group
to ensure that the review process runs as efficiently as possible from the
time an applicant meets with FDA;
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has hired more than 50 new scientific, medical, engineering,
and other review staff, including 14 new statisticians who will be able
to contribute their expertise to the review process;
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has developed a growing medical device fellowship program
that hires outside clinical and academic experts to participate in FDA review
work and train FDA staff, particularly in the field of cardiovascular technology;
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has developed process improvements to speed review from
beginning to end, including a filing review guidance to ensure that submissions
come in with the necessary information for complete review and a continuous
improvement project to streamline the steps to closeout an agency decision
following Panel recommendation.
FDA’s financial report to Congress (required under MDUFMA) is due by
January 2004.
Highlights include:
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Total FY 2003 collections were $21.9 million.
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This is $2.3 million more than estimated in the August
1, 2003 Federal Register notice which set fees for FY 2004.
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FY 2003 collections were still $3.2 million less than
the revenue target of $25.1 million for Fiscal Year 2003 which was set in
the MDUFMA statute.
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Since the final amounts collected in FY03 exceeded the
amount anticipated when the fees were set in August, any collections over
$31.6M in FY04 would be credited to the amounts that industry would be required
to pay in FY 05.
