Important changes to US FDA registration process

If your company is currently registered with the US FDA, we wanted to make you aware of an important change in the way the FDA will collect the annual Establishment Registration fee.

Starting October 1, the FDA Establishment Registration fee must be paid BEFORE registration can occur. Previously, you could register your company and then send payment to the FDA. You will no longer be able to do this. Once FDA has received your payment, a Payment Confirmation Number (PCN) will be provided to you which is required to complete your registration.

All companies must complete both the payment and registration process between OCTOBER 1 and DECEMBER 31, 2008. You are advised to allow for extra time if you intend to pay your fees by mailing a check since registration cannot occur until FDA has received the check and has provided the PCN.

If you did not receive the notice from the FDA with the new payment instructions, you can download it here:

http://www.fda.gov/cdrh/mdufma/FY09UserFeeReg.pdf

The 2009 FDA Establishment Registration fee is US$1851.

As always, we will continue to keep you updated on regulatory issues as needed.

Best Regards,

Evangeline Loh Ph.D. RAC
Director of Regulatory Affairs
Emergo Group, Inc.