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For FDA registration of medical devices, manufacturers are generally required to provide product materials in English. This includes all labeling, instructions for use, and any other documentation intended for distribution in the United States. The FDA mandates that all information submitted to support device registration, such as data summaries, technical specifications, and clinical study reports, must be in English.

English is the official language of communication with the FDA for regulatory submissions and interactions. Providing documentation in English ensures clarity and consistency in the review process, enabling FDA reviewers to thoroughly evaluate device safety, effectiveness, and compliance with regulatory requirements.

However, if the device labeling or instructions are intended for use in bilingual or multilingual markets within the United States, manufacturers may also provide translations into other languages commonly spoken by the intended user population. This can include languages such as Spanish or other languages prevalent in specific demographic or regional markets.

Manufacturers should ensure that translations are accurate and comply with FDA requirements for readability and comprehension by end-users. The FDA may request translations or summaries of key information in English to facilitate review and ensure that all regulatory standards are met.

In summary, while English is the primary language required for FDA registration of medical devices, additional translations may be necessary for markets where bilingual or multilingual labeling and instructions are essential for safe and effective device use.

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