FDA’s New Import Screening Tool PREDICT – Overview and Current Status

The FDA announced plans in 2009 to replace its screening tool for imports, OASIS, with PREDICT or Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting. PREDICT, a web based risk assessment tool, which was initially implemented as a pilot program in Los Angeles in September 2009, before a nation-wide rollout, is expected to assist entry reviewers in examining higher-risk shipments only. PREDICT is integrated into the FDA’s Mission Accomplishments and Regulatory Compliance Services (MARCS) Imports Entry Review software.

 

The system will expedite the clearance of lower-risk cargo if accurate and complete data is provided by importers and entry filers. The PREDICT tool will improve the FDA’s ability to detect trends and investigate patterns.

 

Around 15 to 20 percent of food consumed in the US is imported – this includes 40 percent of all fresh product and 80 percent of seafood. Besides food, large numbers of pharmaceutical ingredients, drugs and devices are also imported. Because of these huge numbers of imports, it is not possible for FDA inspectors to examine every shipment of products coming into the country. A new risk-based, automated approach and system was required to expedite the process.

 

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The PREDICT tool is web-based and designed to help border inspectors monitor products, especially higher risk ones, at the port of entry. The tool is part of a system in which inspectors use barcode scanners linked to a centralized database. If it’s high risk, the tool will raise an alert signaling this. PREDICT uses historical data, patterns and violations to generate a numerical score for FDA regulated products that are imported. The data also includes importer, manufacturer, country of origin as well as post lab results and information related to FDA inspections of foreign facilities. Natural disasters, contamination outbreaks and foreign recalls are also part of the tool’s database, making it possible for the system to flag high risk imports.

The FDA has a specified threshold to designate products as high risk. If the PREDICT score generated through examination at port of entry goes above the FDA-specified threshold, the agency’s inspectors are notified of the same.

 

While food is automatically considered a high risk commodity, each FDA center responsible for regulating other products has to rank the risks associated with them.

 

Products shipped by a company using a sister company’s MID or FDA Registration Number will be detected by artificial intelligence tools available to assist in the detection of anomalies, associations, and shipping patterns. Electronic analysis along with traditional investigative avenues will help in detecting spurious imports. The FDA will take appropriate regulatory action against firms and individuals that ship products in violation of its laws and regulations.

 

As of April 2011, the FDA had implemented the PREDICT system in four out of 20 districts – Los Angeles, New York, San Francisco and Seattle. In testimony to a congressional oversight panel in April, FDA Commissioner Margaret Hamburg said that the FDA expects to implement the PREDICT tool at all ports by the end of 2011.

 

At the end of April, 50 percent of FDA regulated products being imported were being scanned under the new system. The delays, Commissioner Hamburg explained in her testimony, were mainly due to technical difficulties and the sheer scale of implementation required. She said, "This year we expect nearly 24 million shipments of food, devices, drugs, cosmetics radiation-emitting products, and tobacco products will arrive at U.S. ports of entry. Just a decade ago, that number was closer to 6 million, and a decade before only a fraction of that."