Registration of Certain Foreign Establishments Act
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.
Bill status
in committee
1 of 4 stages cleared
Introduction
Jan 2022
Committee Review
Floor Vote
President
Introduced Jan 10, 2022
Last action Jan 10, 2022
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
0
Committee
1
Jan 10, 2022
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
Jan 10, 2022
Introduced
Introduced in Senate
upper
1 primary · 1 co-sponsor
Sponsors
Ask Maddy
·
AI policy assistant
Ask Maddy about S 3449
Scope: US
Hi! I can help you understand S 3449. What would you like to know?
Try one of these
i
Maddy answers using official bill text and legislative records. Always verify before sharing.
Sources cited inline