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Food & Drug Administration Seeks Public Input on Export of Medical Devices; Foreign Letters of Approval Information Collection
June 16, 2025
WASHINGTON, June 16 (TNSFRinfo) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued an information collection notice entitled "Export of Medical Devices; Foreign Letters of Approval." The agency is providing an opportunity for public comment on this proposed collection.

This collection focuses on reporting requirements for companies that intend to export certain unapproved medical devices. Section 801(e)(2) of the Federal Food, Drug, . . .

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