Medical Device Electronic Labeling Act

Summary

Medical Device Electronic Labeling Act This bill expands the permitted use of electronic labeling of medical devices to allow directions for use and warning labels for all medical devices to be provided electronically, rather than physically (i.e., affixed to or accompanying the device or its container).  (Under current law, direction and warning labels may be provided electronically only for (1) prescription devices intended for use in health care facilities or by health care professionals, and (2) in vitro diagnostic devices intended for use in blood establishments or by health care professionals.) Under the bill, direction and warning labels may be provided solely electronically for all medical devices so long as (1) the electronic label is readily accessible to the device’s intended users, (2) intended users may request a paper label at no additional cost, and (3) the label affixed to the device or its packaging contains all information required under current laws and regulations.  The Food and Drug Administration may issue regulations establishing additional requirements or exceptions to these provisions. 

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Timeline

1. 24 February 2025

   Introduced

   Introduced in House

   Source: IntroReferral

2. 24 February 2025

   Introduced

   Introduced in House

   Source: IntroReferral

3. 24 February 2025

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

Votes

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Versions

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Documents

2 official files

• Introduced in House

  Introduced in House · EN · 24 February 2025

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 24 February 2025

  Open at official source

Sponsors

• Jay Obernolte · R · Sponsor
• Rep. Mullin, Kevin [D-CA-15] · D · Sponsor
• Dan Crenshaw · R · Sponsor
• Angie Craig · D · Sponsor
• Scott Peters · D · Cosponsor
• Mariannette Miller-Meeks · R · Cosponsor
• Rep. Bilirakis, Gus M. [R-FL-12] · R · Cosponsor
• Rep. Gottheimer, Josh [D-NJ-5] · D · Cosponsor
• · hsif00 · Standing

Related records

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