Registration of Certain Foreign Establishments Act

United States117th CongressS-3449Senate
Updated: Jan 10, 2022

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 texts

Available versions
Introduced (Senate)View official text

1 version available

All available records shown.

Timeline

  1. Introduced in Senate

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

    Senate

All available records shown.