FDA update – April 18 2011

FDA's PREDICT Application to Launch Nationally

PREDICT-Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting application was first launched at the two largest FDA districts, in Los Angeles and then in New York last year. It has been deployed in Seattle and San Francisco as well, covering about 40 percent of all imports. This month, PREDICT will be implemented in FDA’s Florida and San Juan Districts, expanding coverage to almost 50 percent of all imports. If successful, it will then be rolled out across the country. PREDICT’s role is to help in protection of our nation's supply of food and medical products in an increasingly globalized market.

Characteristics of PREDICT are listed below:

  • PREDICT represents a significant enhancement to FDA's targeting ability by enabling the Agency to use data from a much wider range of sources to inform agency’s entry decisions. With PREDICT, FDA investigators will still physically examine only a small percentage of all import shipments-a limitation that reflects resource realities-but they will have better intelligence available at their fingertips to decide which shipments to examine.
  • PREDICT uses a variety of assessments to rank import shipments according to risk. It considers everything from whether a product is intrinsically risky-such as fresh produce or soft cheeses to Information we have acquired from previous sample analysis, field examinations, or Inspections of shippers or producers and information about the regulatory system under which the product was produced. We can even add information on factors such as floods, hot weather, or market conditions that suggest whether a particular shipment is at risk of being contaminated, Spoiled or otherwise defective. These and other factors are weighed to give a risk score in relation to other products being offered for importation. This score, along with FDA's expertize will allow FDA field staff to target shipments that pose the highest risk to the public health.
  • PREDICT offers many benefits to FDA staff as well as to importers and to the public. By better identifying potentially higher-risk shipments, FDA resources can be focused on those shipments more likely to contain a violative product, providing for a more efficient use of resources and allowing investigators to focus on products most likely to present a risk to the public and to prevent those found violative from entering U.S. commerce.
  • PREDICT automatically clears almost three times as many entry lines of lower-risk products compared to the old system. This allows entry reviewers to devote more time to targeting higher-risk products tor examination. Second, by better identifying lower-risk and compliant products, we are able to expedite their entry resulting in savings to both importers and consumers, by bringing safe products into the country faster.

PREDICT has been instrumental in the detection of violative products that might otherwise have escaped detection.

PREDICT is an exciting innovation that harnesses advances in information science to enable FDA to do their job better and to improve their service to the nation. But, as we know that, it is just one step in FDA’s efforts to fully secure the supply chain.

For more information on PRDICT you can go to the following link:http://democrats.energycommerce.house.gov/sites/default/files/image_uploads/Testimony_04.13.11_Hamburg.pdf  or contact mdi at info@mdiconsultants.com  REF: PREDICT.