Registration of Certain Foreign Establishments Act

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 10 January 2022

   Introduced

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

   Source: IntroReferral

2. 10 January 2022

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 10 January 2022 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 10 January 2022

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 10 January 2022

  ViewDownloadOpen at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in Senate

  summary · EN · 10 January 2022

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Peters, Gary C. [D-MI] · D · Sponsor
• Sen. Collins, Susan M. [R-ME] · R · Sponsor
• · sshr00 · Standing

Related records

• related to ← PREVENT Pandemics Act