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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SUBCHAPTER 1.1 - ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS

 1.1 - ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS

Definition: the term document applies to official records which are considered to be U.S. Government property regardless of the media, e.g., Regulatory notes (electronic and hardcopy), memoranda, inspection reports, e-mails, and official government forms (e.g., SF-71, FDA-482, FDA-483, etc.)

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.