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Wednesday, May 16, 2012
FDA Agreement On Medical Device User Fees
FDA and industry reach agreement in principle on medical device user fees
FDA and representatives from the medical device industry have reached
an agreement in principle on proposed recommendations for the third
reauthorization of a medical device user fee program.
recommendations would authorize the FDA to collect $595 million in user
fees over five years, plus adjustments for inflation. Details of the
agreement, such as the fee structure, are expected to be finalized soon.
a user fee program, industry agrees to pay fees to help fund a portion
of the FDA’s device review activities while the FDA agrees to overall
performance goals such as reviewing a certain percentage of applications
within a particular time frame.
The agreement in principle is the
result of over a year of negotiations between the FDA and industry. It
strikes a careful balance between what industry agreed to pay and what
the FDA can accomplish with the amount of funding proposed. It would
result in greater accountability, predictability, and transparency
through such improvements as a more structured pre-submission process
and earlier interactions between FDA and applicants. With the
additional funding, the FDA would be able to hire over 200 full-time
equivalent workers by the end of the five-year program. The FDA and
industry expect that the agreement in principle would result in a
reduction in average total review times.
“I want to commend my
staff and representatives from industry for their tireless work and
commitment to achieving an agreement in principle on medical device user
fees,” said FDA Commissioner Margaret A. Hamburg, M.D.
“Reauthorization of this important program is an essential component for
advancing medical device innovation.”
The industry associations
who have reached an agreement in principle with the FDA include the
Advanced Medical Technology Association, the Medical Device
Manufacturers Association and the Medical Imaging and Technology
Congress first established the user fee program 10 years
ago with the Medical Device User Fee and Modernization Act of 2002
(MDUFA I), prompted by growing concerns about the capacity and
performance of the medical device review program. The five-year program
was reauthorized with the Medical Device User Fee Act of 2007 (MDUFA II)
and is set to expire on Sept. 30.
MDUFA II authorized FDA to
collect user fees for certain medical device applications, for the
registration of certain medical device establishments, and for certain
other purposes. Small businesses may qualify for a waiver from fees on
certain submissions or may qualify for a reduced fee.
2010, prior to beginning negotiations with regulated industry, the FDA
held a public meeting on the device user fee program attended by a
variety of stakeholders including industry, scientific and academic
experts, health care professionals, and representatives from patient and
consumer advocacy groups. Stakeholders provided their assessment of the
overall performance of the MDUFA program and their opinions about which
aspects of the program should be retained, changed, or discontinued in
order to further strengthen and improve the program.
final details of the agreement with industry is completed, FDA will
develop a package of proposed recommendations and give the public an
opportunity to comment before they are submitted to Congress.
The date of the public meeting has yet to be determined.
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation's food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
For Immediate Release: Feb. 1, 2012 Media Inquiries: Karen Riley, 301-796-4674,