Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 1.1 - ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS

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Records or Federal Records are defined in 44 U.S.C. 3301 as including "all books, papers, maps, photographs, machine readable materials, or other documentary materials, regardless of physical form or characteristics which includes regulatory notes, memoranda, inspection reports, emails and official government forms e.g. SF-71, FDA-482-FDA-483, etc. made or received by an agency of the United States Government under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations or other activities of the Government or because of the informational value of the data in them (44 U.S.C. 3301). (See also § 1222.10 of this part for an explanation of this definition).Highlighted to denote updated text

All official FDA documents generated during your routine duties shall be completed in English. This requirement is necessary to facilitate efficiency in the workplace. For instance, many of your work products used in support of FDA's regulatory process are subject to review and auditing by your supervisor, utilized by your co-workers, and others, including the public, in that they are releasable under the Freedom of Information Act (FOIA). The Agency does not have the resources to assure the accurate and timely English translation of documents written in a non English language in order to facilitate their use in the conduct of official business. English is generally considered to be the common language of the U.S.; therefore it is necessary to standardize the language utilized in the production of official FDA documents.

Additionally, FDA imposes English only requirements on the public for information submitted to the Agency. For example 21 Code of Federal Regulations section 803.13(a) (English Reporting Requirement) states that all reports required in this part which are submitted in writing or electronic equivalent shall be submitted to FDA in English.

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Page Last Updated: 12/18/2014
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