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Registration of Certain Foreign Establishments Act

USA117th CongressS-3449| Senate 
| Updated: 1/10/2022
Gary C. Peters

Gary C. Peters

Democratic Senator

Michigan

Cosponsors (1)
Susan M. Collins (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jan 10, 2022
Introduced in Senate
Jan 10, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 10, 2022
    Introduced in Senate


  • January 10, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • S 117-3799: PREVENT Pandemics Act
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth technology, devices, suppliesLicensing and registrationsManufacturing

Registration of Certain Foreign Establishments Act

USA117th CongressS-3449| Senate 
| Updated: 1/10/2022
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. 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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jan 10, 2022
Introduced in Senate
Jan 10, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 10, 2022
    Introduced in Senate


  • January 10, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Gary C. Peters

Gary C. Peters

Democratic Senator

Michigan

Cosponsors (1)
Susan M. Collins (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 117-3799: PREVENT Pandemics Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth technology, devices, suppliesLicensing and registrationsManufacturing