FDA 3601 Medical Device User Fee Cover Sheet

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Form Approved: OMB No. 0910-0511 Expiration Date: August 31, 2022. 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:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ucm370879.htm
1. COMPANY NAME AND ADDRESS (include name, street address, city state, 2. CONTACT NAME
country, and post office code)
2.1 E-MAIL ADDRESS
2.2 TELEPHONE NUMBER (include Area code)
2.3 FACSIMILE (FAX) NUMBER (Include Area code)
1.1 EMPLOYER IDENTIFICATION NUMBER (EIN)
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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm345263.htm
Select an application type:
3.1 Select a center
[ ] Premarket notification(510(k)); except for third party
[ ] CDRH
[ ] 513(g) Requestfor Information
[ ] CBER
[ ] Biologics LicenseApplication (BLA)
3.2 Select one of the types below
[ ] Premarket Approval Application (PMA)
[ ] Original Application
[ ] Modular PMA
Supplement Types:
[ ] Product Development Protocol (PDP)
[ ] Efficacy (BLA)
[ ] Premarket Report (PMR)
[ ] Panel Track (PMA, PMR, PDP)
[ ] 30-Day Notice
[ ] Real-Time (PMA, PMR, PDP)
[ ] De Novo Request
[ ] 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
[ ] NO, I am not a small business
qualifying 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 your establishments have registered and paid the fee, or this is your first device and you will register and pay the
fee within 30 days after entering into an operation that requires you to register and submit device listing information.)
[ ] NO (If you currently market a medical device and your establishment is required to register and submit device listing
information, FDA will not accept your submission until you have paid all fees due to FDA. See
http ://www.fd a .g o v/M ed icalDev ices /DeviceReg ulatio nand G uid ance /Ho wto Ma rketYo urDevice /Reg istra tio na nd Listing /ucm0 53 165 .htm
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
[ ] The sole purpose of the application is to support
business, including any affiliates
conditions of use for a pediatric population
[ ] This biologics application is submitted under section 351 of the
[ ] The application is submitted by a state or federal
Public Health Service Act for a product licensed for further
government entity for a device that is not to be distributed
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
PAPERWORK REDUCTION ACT STATEMENT
Public reporting burden for this collection of information is estimated to average 18 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing
the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to the address below.

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8/10/2021

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Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paper Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
[Please do NOT return this form to the above address, except as it pertains to comments on the burden estimate.]
8. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET APPLICATION
$
Form FDA 3 6 0 1 (0 8/1 9)

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