United States · Bill · S
S. 3449 (117th)
Registration of Certain Foreign Establishments Act
Introduced
10 January 2022
Last action
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Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
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Subjects
Discovery layer
Source updated
21 April 2025
Summary
Registration of Certain Foreign Establishments Act This bill expands statutory provisions that require foreign manufacturers of drugs or medical devices for the U.S. market to register with the Food and Drug Administration. Specifically, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug or medical device to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug or medical device in question undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.
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Documents
3 official files
Introduced in Senate (text)
Introduced in Senate (text)
Introduced in Senate · EN · 10 January 2022
Introduced in Senate (PDF)
Introduced in Senate · EN · 10 January 2022
Introduced in Senate
summary · EN · 10 January 2022
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Sources
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- Official source: https://www.congress.gov/bill/117th-congress/senate-bill/3449
- Open data entity: https://api.congress.gov/v3/bill/117/s/3449