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S 3449 117th Congress Senate Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Licensing and registrations Manufacturing

Registration of Certain Foreign Establishments Act

Introduced: January 10, 2022 Introduced by: Peters, Gary C. Democratic · Michigan See on congress.gov
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 10, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jan 10, 2022
Introduced in Senate
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 Plain-English summary Congressional Research Service

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.

What's happening now January 10, 2022

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 1
All 1 Republican 1
R
Collins, Susan M.
Maine · Jan 10, 2022
Cite this page click to expand
APA
U.S. Congress. (2026). S. 3449: Registration of Certain Foreign Establishments Act. 117th Congress. Open America. https://openamerica.io/bill/117-S-3449/
MLA
"S. 3449: Registration of Certain Foreign Establishments Act." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-S-3449/.
Bluebook (legal)
S. 3449, 117th Cong. (2026), https://openamerica.io/bill/117-S-3449/.
Markdown link
[S. 3449: Registration of Certain Foreign Establishments Act](https://openamerica.io/bill/117-S-3449/)
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