Registration of Certain Foreign Establishments Act

Senate Bill 3449 - Registration of Certain Foreign Establishments Act: Overview, Status, and Impact

Hozzl · 2022-12-30T03:48:58Z

Explore the details of Senate Bill 3449 Registration of Certain Foreign Establishments Act currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

12/30/2022, 3:48 AM

Congressional Summary of S 3449

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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Current Status of Bill S 3449

Bill S 3449 is currently in the status of Bill Introduced since January 10, 2022. Bill S 3449 was introduced during Congress 117 and was introduced to the Senate on January 10, 2022. Bill S 3449's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of January 10, 2022

Bipartisan Support of Bill S 3449

Total Number of Sponsors

Democrat Sponsors

Republican Sponsors

Unaffiliated Sponsors

Total Number of Cosponsors

Democrat Cosponsors

Republican Cosponsors

Unaffiliated Cosponsors

Policy Area and Potential Impact of Bill S 3449

Primary Policy Focus

Health

Potential Impact Areas

- 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

Alternate Title(s) of Bill S 3449

Registration of Certain Foreign Establishments Act

A 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.