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
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
Plain-English 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.
What's happening now
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees of jurisdiction
1
Cosponsors
1