Are you ready for FY 2009 changes including paying user fees prior to registration? Here's a DOTmed exclusive briefing on what you need to know before the federal fiscal year.

The Food and Drug Administration (FDA) has announced that there are significant new changes to its Device Facility User Fee and Registration, taking place as of October 1, 2008. The changes impact facilities that are required to pay the device facility user fee.

The major change in the process will be that a facility must pay the user fee before registering the facility--the facility cannot register until the user fee is paid. If both the payment and registration are not correctly submitted, or not complete, the facility registration will be incomplete until corrected. Firms must complete the payment and registration between October 1, 2008 and December 31, 2008. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. The fee for FY 2009 is $1,851.
The following entities must pay a facility user fee:
--U.S. or foreign based manufacturer of devices that are commercially
distributed in the U.S.
--U.S. manufacturer of devices produced for export out of the U.S. only
--U.S. contract manufacturer who commercially distributes the device for the
specifications developer
--U.S. contract sterilizer who commercially distributes the device
--Foreign contract manufacturer or sterilizer whose device is shipped to the U.S. either by the contract manufacturer or by any other foreign establishment
--Reprocessor of single-use devices commercially distributed in the U.S.
--Developer of specifications for a device that is manufactured by another party
--Kit Assembler

When accessing the registration website, the facility must create an account to enter the website. Domestic firms must enter their taxpayer ID. A facility does not need to create an account if it has signed up with another FDA user fee website in the past but can use that same account information to log onto this website. The ID and password for the Facility User Fee website will be different than a FURLS ID and password.

Once logged onto the website with the username and password created, the facility can then enter the quantity of user fees needed to pay. The screen displays a Payment Identification Number (PIN). The PIN will be needed to register the facility and should be recorded. Once payment is completed online and processed by the FDA, the facility will receive an email with a unique Payment Confirmation Number (PCN) for each facility paying a user fee. One PCN confirms a payment for one facility. The PCN(s) will also be needed to register a facility and should be recorded.

If a facility did not pay a user fee because it is not required to, it may review the annual registration or enter new information on the FURLS site. Those facilities paying a user fee and receiving the PIN and PCN can review and enter its registration information once logged onto FURLS.

The FDA recommends that a facility ensures it has plenty of time to process the payment and confirm the registration before December 31, 2008, specially if paying by check. The payment processing can take up to two weeks. Registration is not complete until FDA notifies a facility that all requirements have been met.

The FDA Facility User Fee website: https://fdasfinapp8.fda.gov/OA_HTML/furls.jsp
FURLS website: https://www.access.fda.gov/oaa/
More information on FDA Device Registration: http://www.fda.gov/cdrh/reglistpage.html

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