On June 15th, 2016, it will become mandatory that reporting of imports to the U.S. Food and Drug Administration be done through the new ACE system. In order to expedite clearance of FDA regulated products, the ACE system will interface with FDA's targeting system, PREDICT. This will allow FDA to quickly release "lower risk" products, while focusing attention on "higher risk" products.

 

This means that new data elements will be required in regards  to your imported product. FDA will hold shipments where names, addresses and numbers of manufacturers, shippers, and importers do not match, or shipments that are missing correct codes, so giving accurate information is imperative.

 

Although the new data elements vary according to the product class, some examples are: Intended Use Codes, Affirmation of Compliance Codes, and FEI numbers for all parties.

 

Please take time to review and fill out the form associated with your imported product, noting the new elements. Once done, please forward back to us, so we may update your database. This will greatly assist our effort to accelerate your shipment through FDA.

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Thank you,

 

Casey Hughes

 

Import Manager

Licensed Customs Broker

Robert E. Landweer & Co., Inc.

P.O. Box 68369, Seatac, WA 98188

Tel# 206-623-5335 Ext. 8

Fax# 206-343-9253

email: chughes@relandweer.com