FDA 医疗器械 2012 收费标准

工厂年费的付款方法和步骤

VII. Procedures for Paying Annual Establishment Fees

In order to pay the annual establishment fee, firms must access the Device

Facility

User

Fee

(DFUF)

Web

site

at

https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the Web site address, but FDA is

not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register). The Web site includes a short interactive questionnaire to help you ascertain whether an annual registration payment is required for your type of facility. If you are required to pay an annual establishment registration fee, you must pay for each establishment prior to registration. You will create a DFUF order and you will be issued a PIN once you place your order. After payment has been processed, you will be issued a payment confirmation number (PCN). You will not be able to register your establishment if you do not have a PIN and a PCN. An establishment required to pay an annual establishment registration fee is not legally registered in FY 2012 until it has completed the steps in the paragraphs that follow to

register and pay any applicable fee. (See 21 U.S.C. 379j(f)(2).)

Companies that do not manufacture any product other than a licensed biologic are required to register in the Blood Establishment

Registration (BER) system. FDA's Center for Biologics Evaluation and Research (CBER) will send establishment registration fee invoices annually to these companies.

A. Step One--Submit a Device Facility User Fee (DFUF) Order With a PIN

From FDA Before Registering or Submitting Payment

To submit a DFUF order, you must create or have previously created a user account and password through the User Fee Web site listed previously in this section. After creating a user name and password, log into the Establishment Registration User Fee 2012 store. Complete the DFUF order by entering the number of establishments you are registering that require payment. Once you are satisfied that the data on the order is accurate, electronically transmit that data to FDA according to instructions on the screen. Print a copy of the final DFUF order and note the unique PIN located in the upper right-hand corner of the printed order.

B. B. Step Two--Pay For Your Device Facility User Fee Order

Unless paying by credit card, all payments must be in U. S. currency and drawn on a U.S. bank.

1. If paying with a credit card or electronic check (ACH):

The DFUF order will include payment information, including details on how you can pay online using a credit card or electronic checks. Follow the instructions provided to make an electronicment. 2. If paying with a paper check:

If you prefer not to pay online, you may pay by a check, in U.S. dollars and drawn on a U.S. bank, mailed to: U.S. Bank, Attn:

Government Lockbox 979108, St. Louis, MO 63197-9000. (Note: This address is different from the address for payments of application and annual report fees and is to be used only for payment of annual establishment registration fees.)

If a check is sent by a courier that requests a street address, the courier can

deliver the check to:

U.S. Bank, Attn: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101.

(Note: This U.S. Bank address is

for courier delivery only; do not send mail to this address.)

Please make sure that both of the following are written on your

check: (1) The FDA lockbox number (Lockbox 979108) and (2) the PIN that is printed on your order. A copy of your printed order should also be mailed along with your check. FDA's tax identification number is 53- 0196965.

3. If paying with a wire transfer:

Wire transfers may also be used to pay annual establishment fees. To send a wire transfer, please read and comply with the following information:

Include your order's unique PIN, from the upper right-hand

corner of your completed Medical Device User Fee order, in your wire transfer. Without the PIN your payment may not be applied to your facility and your registration will be delayed.

The originating financial institution usually charges a

wire transfer fee between $15 and $35. Please ask your financial institution about the fee and include it with your payment to ensure that your order is fully paid. Use the following account information when sending a wire transfer: New York Federal Reserve Bank, U.S. Dept of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 5600 Fishers Lane, Rockville, MD 20857.

C. C. Step Three--Complete the Information Online To Update Your

Establishment's Annual Registration for FY 2012, or to Register a New Establishment for FY 2012

Go to CDRH's Web site at

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm and click the ``Access Electronic

Registration'' link on the left of the page. This opens up a new page with important information about the FDA Unified Registration and Listing System (FURLS). After reading this information, click on the link (Access Electronic Registration) at the bottom of the page. This link takes you to an FDA Industry Systems page with tutorials that demonstrate how to create a new FURLS user account if your establishment did not create an account in FY 2010 or FY 2011. Biologics

manufacturers

should

register

in

the

BER

system

at

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.

Enter your existing account ID and password to log into FURLS. From the FURLS/FDA Industry Systems menu, click on the Device Registration and Listing Module (DRLM) of FURLS button. New establishments will need

to register and existing establishments will update their annual registration using selections on the DRLM menu. Once you choose to register or update your annual registration, the system will prompt you through the entry of information about your establishment and your devices. If you have any problems with this process, e-mail:

reglist@cdrh.fda.gov or call 301-796-7400 for assistance. (Note: this e-mail address and this telephone number are for assistance with establishment registration only, and not for any other aspects of medical device user fees.) Problems with BER should be directed to bloodregis@fda.hhs.gov or call 301-827-3546.

D. Step Four--Enter Your DFUF Order PIN and PCN

After completing your annual or initial registration and device listing, you will be prompted to enter your DFUF order PIN and PCN, when applicable. This process does not apply to licensed biologic devices. CBER will send invoices for payment of the establishment registration fee to companies who only manufacture licensed biologics devices. Fees are only required for those establishments defined in section I of this document.

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