Registration of Certain Foreign Establishments Act

12/30/2022, 3:48 AM

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.

Congress
117
Number
S - 3449
Introduced on
2022-01-10
# Amendments
0
Sponsors
+5
Cosponsors
+5

Variations and Revisions

1/10/2022
Text
PDF
XML

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and 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.

Alternative Names
Official Title as IntroducedA bill to require foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device to register with the Food and Drug Administration regardless of whether the drug or device undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported into the United States.
Policy Areas
Health
Potential Impact
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

Comments

Recent Activity

Latest Summary8/5/2022

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...

Latest Action1/10/2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.