Registration of Certain Foreign Establishments Act

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.