DEPARTMENT
OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG
ADMINISTRATION
MEDICAL
DEVICE USER FEE COVER SHEET
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PAYMENT
IDENTIFICATION NUMBER:
MD604XXXX-956733
Write
the Payment Identification number on your check.
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A
completed cover sheet must accompany each original
application or supplement subject to fees. If payment is
sent by U.S. mail or courier, please include a copy of
this completed form with payment. Payment and mailing
instructions can be found at:
http://www.fda.gov/oc/mdufma/coversheet.html
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1.
COMPANY NAME AND ADDRESS (include name, street address,
city state, country, and post office code)
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1.1
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EMPLOYER
IDENTIFICATION NUMBER (EIN)
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2.
CONTACT NAME
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2.1
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E-MAIL
ADDRESS
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2.2
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TELEPHONE
NUMBER (include Area code)
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2.3
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FACSIMILE
(FAX) NUMBER (Include Area code)
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3.
TYPE OF PREMARKET APPLICATION (Select one of the
following in each column; if you are unsure, please refer
to the application descriptions at the following web
site: http://www.fda.gov/oc/mdufma
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Select
an application type:
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3.1
Select a center
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[
] Premarket notification(510(k)); except for third
party
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[
] CDRH
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[ ] 513(g)
Request for Information
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[ ] CBER
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[ ] Biologics
License Application (BLA)
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3.2
Select one of the types below
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[ ] Premarket
Approval Application (PMA)
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[
] Original Application
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[ ] Modular
PMA
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Supplement
Types:
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[ ] Product
Development Protocol (PDP)
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[ ] Efficacy
(BLA)
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[ ] Premarket
Report (PMR)
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[ ] Panel
Track (PMA, PMR, PDP)
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[ ] Annual
Fee for Periodic Reporting (APR)
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[ ] Real-Time
(PMA, PMR, PDP)
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[ ] 30-Day
Notice
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[ ] 180-day
(PMA, PMR, PDP)
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4.
ARE YOU A SMALL BUSINESS? (See the instructions for more
information on determining this status)
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[ ] YES,
I meet the small business criteria and have submitted the
required qualifying documents to FDA
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[X] NO,
I am not a small business
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4.1
If Yes, please enter your Small Business Decision
Number:
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5. FDA
WILL NOT ACCEPT YOUR SUBMISSION IF YOUR COMPANY HAS NOT
PAID AN ESTABLISHMENT REGISTRATION FEE THAT IS DUE TO
FDA. HAS YOUR COMPANY PAID ALL ESTABLISHMENT REGISTRATION
FEES THAT ARE DUE TO FDA?
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[
] YES (All of our establishments have registered and
paid the fee, or this is our first device, and we will
register and pay the fee within 30 days of FDA's
approval/clearance of this device.)
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[ ] NO
(If "NO," FDA will not accept your submission
until you have paid all fees due to FDA. This submission
will not be processed; see http://www.fda.gov/cdrh/mdufma
for additional information)
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6.
IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE
FOLLOWING USER FEE EXCEPTIONS? IF SO, CHECK THE
APPLICABLE EXCEPTION.
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[ ] This
application is the first PMA submitted by a qualified
small business, including any affiliates
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[ ] The
sole purpose of the application is to support conditions
of use for a pediatric population
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[ ] This
biologics application is submitted under section 351 of
the Public Health Service Act for a product licensed for
further manufacturing use only
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[ ] The
application is submitted by a state or federal government
entity for a device that is not to be distributed
commercially
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7.
IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH
FEES WERE WAIVED DUE TO SOLE USE IN A PEDIATRIC
POPULATION THAT NOW PROPOSES CONDITION OF USE FOR ANY
ADULT POPULATION? (If so, the application is subject to
the fee that applies for an original premarket approval
application (PMA).
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[ ] YES
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[
] NO
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8.
USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET
APPLICATION
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$XX,XXX.00
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DD-MMM-YYYY
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