DEVICE Act of 2019

Summary

Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2019 or the DEVICE Act of 2019 This bill addresses design changes and reprocessing of medical devices. Reprocessing of medical devices is the process to clean and sterilize or disinfect devices for reuse. Specifically, medical device manufacturers must notify the Food and Drug Administration (FDA) (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. A device may not be sold if the manufacturer violates these notification requirements. Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.

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Timeline

1. 28 January 2019

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 28 January 2019

   Introduced

   Introduced in House

   Source: IntroReferral

3. 28 January 2019

   Introduced

   Introduced in House

   Source: IntroReferral

4. 29 January 2019

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 28 January 2019 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 28 January 2019

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 28 January 2019

  ViewDownloadOpen at official source

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  Vertaal document

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• Introduced in House

  summary · EN · 28 January 2019

  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
• Rep. Cummings, Elijah E. [D-MD-7] · D · Sponsor
• Del. Norton, Eleanor Holmes [D-DC-At Large] · D · Sponsor
• Rep. Grijalva, Raúl M. [D-AZ-7] · D · Sponsor
• · hsif00 · Standing

Related records

• related to → DEVICE Act of 2021
• related to ← DEVICE Act of 2017