AdvaMed® Welcomes Senate Introduction of Bipartisan Medical Device Electronic Labeling Bill

AdvaMed® Welcomes Senate Introduction of Bipartisan Medical Device Electronic Labeling Bill

• Regulatory Affairs
• May 14, 2026

Washington, D.C.-AdvaMed, the Medtech Association, the world's biggest trade association representing medtech innovators, welcomed Senate introduction of the bipartisan Medical Device Electronic Labeling Act (S. 4519), which would allow medtech instructions for use to be provided electronically, with paper copies being available upon request.

"Doctors and patients increasingly turn to online resources for information about how to use medtech," said Scott Whitaker, AdvaMed President and CEO. "Electronic instructions are easy for consumers to access and for manufacturers to update quickly, without the delay caused by issuing paper manuals.

"This efficiency would help doctors and patients use the medtech as effectively as possible, achieving the full intended benefits of each innovation. We thank Senators Banks and Hickenlooper for working to modernize this critical aspect of health care. With this, we now have bipartisan e-labeling bills in both houses of Congress, so there's no reason we can't get them passed and signed into law this year."

Electronic labeling of medtech offers several benefits:

• Timely Updates: Electronic labeling allows manufacturers to update safety information and usage instructions more quickly, ensuring users always have the most current guidance.
• Improved Readability: Digital formats enable patients to adjust font sizes or use screen readers, which is especially beneficial for those with visual impairments who may struggle with the tiny print on folded paper inserts.
• Rich Media Integration: Manufacturers can include instructional videos, interactive FAQs, and infographics that can be more effective at demonstrating proper device usage than static text.

The Senate bill was introduced by Sens. Jim Banks (R-Ind.) and John Hickenlooper (D-Colo.).

The bill is similar to the bipartisan Medical Device Electronic Labeling Act, H.R. 1539, introduced last year in the House of Representatives by Reps. Jay Obernolte (R-Calif.), Kevin Mullin (D-Calif.), Rep. Dan Crenshaw (R-Texas), and Rep. Angie Craig (D-Minn.)

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