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An In-depth Look at PREDICT for FDA Import Clearance

December 28, 2015

Have you ever heard of PREDICT for FDA import clearance?

When a shipment regulated by the Food and Drug Administration (FDA) arrives at the US border, there are two options: It can either be released immediately by the federal agency without further examination, or it can experience a delay at the American port of entry.

The first option implies that an automated “may proceed” was generated by the FDA import clearance system. FDA uses an electronic screening tool called PREDICT that searches for high risk shipments by calculating risk scores at FDA import operations.

The PREDICT acronym stands for Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting.

  • PREDICT has been fully implemented in the United States since December 2011, but a few of the 16 FDA import districts tested it earlier. The Los Angeles district was the first one to make use of the tool in 2009, achieving “may proceed” success rates of about 45% on entries.
  • Nationwide, when considering the 16 FDA import districts covering over 320 ports of entry, PREDICT is said to allow only about 25% of the shipments to enter the country automatically. Success rate discrepancies between ports of entry originate from the portfolio of commodities being imported and from the quality of the data provided to the federal agency.
  • FedEx Express experienced a sudden increase in the number of delayed shipments when PREDICT was implemented in its 6 FedEx ports of entry. The FDA does not communicate PREDICT automated “may proceed” success rates associated with those ports of entry. However FedEx makes estimates internally by assuming that an international air shipment obtained green light from the FDA clearance tool system if a positive response is obtained within half an hour following data transmission.

FedEx Express has been able to leverage internal lessons learned since PREDICT implementation. The FedEx trade compliance team is working to help shippers optimize elements that are within their control, in particular by verifying information provided on shipping documents.

Safe healthcare shipments with complete and accurate paperwork have a higher probability of entering the US territory without delays.

 


Christelle Laot

Technical Fellow

Dr. Christelle Laot joined FedEx Express in 2007, and is currently Technical Fellow in the FedEx healthcare industry vertical. In this role, she provides direction and raises awareness around trends, transportation regulatory frameworks and shipping solutions. Prior to her work with FedEx, Dr. Laot held managerial positions in R&D, innovation and strategy at Bayer in Germany for about six years.

Dr. Laot obtained PhD and MS in Chemical Engineering from Virginia Tech (USA), a Diplôme d’Ingénieur from UTC Compiègne (France), as well as an MBA from HEC Montreal (Canada).

View all Christelle Laot’s blog posts

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