DEVICE Act of 2021

Summary

Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021 or the DEVICE Act of 2021 This bill addresses design changes and reprocessing of medical devices. Specifically, medical device manufacturers must notify the Food and Drug Administration (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.) A device may not be sold if the manufacturer violates these notification requirements.

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

Timeline

1. 5 February 2021

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 5 February 2021

   Introduced

   Introduced in House

   Source: IntroReferral

3. 5 February 2021

   Introduced

   Introduced in House

   Source: IntroReferral

4. 8 February 2021

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 5 February 2021 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 5 February 2021

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 5 February 2021

  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 House

  summary · EN · 5 February 2021

  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

• Rep. Lieu, Ted [D-CA-36] · D · Sponsor
• Rep. Chu, Judy [D-CA-28] · D · Sponsor
• Del. Norton, Eleanor Holmes [D-DC-At Large] · D · Sponsor
• · hsif00 · Standing

Related records

• related to → DEVICE Act of 2023
• related to ← DEVICE Act of 2019