Improved FDA Import Screening Process
Enhance your understanding of the FDA's import screening process with PREDICT, a risk-based tool for regulated products. Learn about its purpose, methods, and benefits for preventing the entry of violative goods while expediting non-violative ones. Explore how FDA ensures the safety of foods, drugs, medical devices, cosmetics, and more through harmonized data sets and electronic screening. Stay informed about FDA's regulatory programs and TBT measures to maintain product quality and safety standards in the United States.
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Presentation Transcript
PREDICT: A risk-based tool for regulated products
U.S. FDAs Regulatory Programs The Food Drug & Cosmetic Act established FDA as the regulatory body which ensures the safety and efficacy of the following products: Foods Drugs Biologics Medical devices Radiation emitting electronics Cosmetics Veterinary products Tobacco products 2 www.fda.gov
FDA TBT Measures FDA requires that all products covered under the FD&C meet the same technical requirements, whether imported or produced domestically. This includes imports of drugs, medical devices, cosmetics, tobacco, and food which carries nutrition facts labels. 3 www.fda.gov
Single Window A single, harmonized data set collected electronically by CBP Early validation of exporter s paperwork results in better data quality and quicker admissibility decisions Coordinated, consolidated status messaging across agencies 4 www.fda.gov
Import Volume 5 www.fda.gov
PREDICT All imported products that FDA regulates are electronically screened before they enter the United States 6 www.fda.gov
PREDICT Purpose: Improve import screening and targeting to prevent entry of adulterated, misbranded, or otherwise violative goods into the United States and expedite the entry of non-violative goods. Method: Replaced the admissibility portion of FDA s legacy electronic screening process. 7 www.fda.gov
PREDICT - Methods Verification of applicable regulatory requirements, e.g. registration, approval status, etc. Automated data mining and pattern discovery Automated review of administrative requirements Open source intelligence 8 www.fda.gov
PREDICT Improved Targeting Evaluate shipments on the basis of risk factors and surveillance requirements. Facilitate automated releases, giving border inspectors more time to evaluate higher risk lines. For consignments not automatically admitted, identify risk factors for border inspectors to consider in determining disposition. 9 www.fda.gov
PREDICT - Risk Factors Inherent risk of the product Results of field exams and analytical testing of previous entries from the same producer or country. Results of facility inspections (foreign and domestic) Accuracy of import and registration documents 10 www.fda.gov
Additional Information https://www.fda.gov/ForIndustry/ImportProgram/default.htm 11 www.fda.gov
