Worldwide Customs and Regulatory Updates

Provision of Complete Data for FDA Import Declaration

The U.S. Food and Drug Administration (FDA) advises that shipments which contain regulated merchandise are required to provide accurate, consistent and complete data for import declaration.

Recent clearance and release delays have been associated with the national rollout of PREDICT*, a component of the FDA automated system intended to assess the risk of FDA regulated commodities.  Under PREDICT, the FDA requires “Affirmation of Compliance”** codes for certain commodities in order to receive a fully automated release.  Affirmation of Compliance codes primarily apply to medical devices, electronic components, medical and non-medical radiation-emitting products and parts and components of these commodities. 

Customers shipping FDA regulated commodities to the U.S. are advised to check with U.S. importers to:
  • Identify all required data for FDA declaration
  • Include data for each FDA regulated item on shipment documentation
  • Submit product data to FedEx for inclusion on Clearance Profile Guide for use with future shipments

Shipments missing any data required for FDA declaration will be delayed while information is being secured from customers. 

Should you need further assistance, please contact your local FedEx Customer Service Team

* PREDICT stands for Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting.
** Data elements submitted to FDA to expedite the entry review process.