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FDA Issues Information for Foreign Governments: Frequently Asked Questions on Systems Recognition

CFSAN Constituent Update

September 5, 2013

The U.S. Food and Drug Administration today issued “Information for Foreign Governments: Frequently Asked Questions on Systems Recognition.” This document is intended to provide information to foreign governments and other stakeholders on FDA’s proposed systems recognition program including:

  • The rationale for creating the program
  • Implications of the program
  • How systems recognition assessments will be conducted
  • How information collected will be used, and
  • What impact systems recognition may have on processes for importing food.

The FDA Food Safety Modernization Act (FSMA) provides FDA with a variety of new authorities and tools to help ensure the safety of imported foods. While systems recognition is not a FSMA provision, it is part of FDA’s broader toolbox for import safety and is referenced in the recently-published proposed rule on Foreign Supplier Verification Programs (FSVPs). Countries that have been recognized under Systems Recognition would be subject to modified requirements under the proposed FSVP rule.

FDA intends to collect comments on the Frequently Asked Questions document issued today in order to inform its decision-making process as the Agency considers moving forward from a pilot phase in systems recognition to implementation. Note: FDA previously used the term “comparability assessment” to describe the process in the document, but has since adopted the term “systems recognition assessment” as a more descriptive term.

FDA will accept public comments on the FAQ document through a special mailbox,

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