3601 Medical Device User Fee Cover Sheet

Form Approved: OMB No. 0910-511 Expiration Date: January 31, 2010. See Instructions for OMB Statement.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
MEDICAL DEVICE USER FEE COVER SHEET

PAYMENT IDENTIFICATION NUMBER: MD
Write the Payment Identification number on your check.

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
1. COMPANY NAME AND ADDRESS (include name, street
address, city state, country, and post office code)

2. CONTACT NAME
2.1 E-MAIL ADDRESS

1.1 EMPLOYER IDENTIFICATION NUMBER (EIN)

2.2 TELEPHONE NUMBER (include Area code)
2.3 FACSIMILE (FAX) NUMBER (Include Area code)

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
Select an application type:
[ ] Premarket notification(510(k)); except for third party
[ ] 513(g) Request for Information
[ ] Biologics License Application (BLA)
[ ] Premarket Approval Application (PMA)
[ ] Modular PMA
[ ] Product Development Protocol (PDP)
[ ] Premarket Report (PMR)
[ ] Annual Fee for Periodic Reporting (APR)
[ ] 30-Day Notice

3.1 Select a center
[ ] CDRH
[ ] CBER
3.2 Select one of the types below
[ ] Original Application
Supplement Types:
[ ] Efficacy (BLA)
[ ] Panel Track (PMA, PMR, PDP)
[ ] Real-Time (PMA, PMR, PDP)
[ ] 180-day (PMA, PMR, PDP)

4. ARE YOU A SMALL BUSINESS? (See the instructions for more information on determining this status)
[ ] YES, I meet the small business criteria and have submitted the required qualifying [ ] NO, I am not a small business
documents to FDA
4.1 If Yes, please enter your Small Business Decision Number:
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?
[ ] 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.)
[ ] 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)
6. IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCEPTIONS? IF SO, CHECK THE
APPLICABLE EXCEPTION.
[ ] This application is the first PMA submitted by a qualified small business,
[ ] The sole purpose of the application is to support conditions
including any affiliates
of use for a pediatric population
[ ] The application is submitted by a state or federal
[ ] This biologics application is submitted under section 351 of the Public
government entity for a device that is not to be distributed
Health Service Act for a product licensed for further manufacturing use only
commercially
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).
[ ] YES

[ ] NO

8. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET APPLICATION
Form FDA 3601 (01/2007)