Medical Device Electronic Labeling Act
May 13, 2026
Introduced: May 13, 2026
May 13, 2026
Introduced: May 13, 2026
Summary
Lets makers of medical devices put required labels, like instructions and warnings, online instead of on paper, as long as people can still get a paper copy.
What problem does this solve?
Current rules often require medical device makers to include bulky paper instructions with every product, which can be wasteful and hard to update. This bill allows for digital labels that are easier to access and keep current, while still letting users request a free paper copy if they need one.
What does this bill do?
Reference
Text:
Section:
Sec. 2(f)(2)
Header:
Allowing required labeling of devices to be made available solely by electronic means
Allows electronic labeling for medical devices
Permits required labels for medical devices, including in vitro diagnostics, to be provided only in an electronic format, such as online, as long as it is user-friendly.
Reference
Text:
Section:
Sec. 2(f)(2)(B)
Header:
Allowing required labeling of devices to be made available solely by electronic means
Guarantees access to paper copies
Requires manufacturers to give users an easy way to ask for a paper copy of the label at no extra cost and to provide it quickly upon request.
Reference
Text:
Section:
Sec. 2(f)(3)(A)
Header:
Allowing required labeling of devices to be made available solely by electronic means
Grants secretary power to add rules
Allows the Secretary of Health and Human Services to create extra rules or exceptions for electronic labeling, especially for devices used by patients without a doctor's help.
Requires public input on e-labeling
Directs the Secretary of Health and Human Services to ask for public comments within two years on how to improve electronic labels for devices used outside of healthcare settings.
Who does this affect?
- Medical device manufacturers
- Patients and consumers using medical devices
- Healthcare professionals
What is the real world impact?
•
Reduces waste and costs for manufacturers
Saves money for medical device companies by cutting down on printing and shipping costs for paper labels and instruction booklets. This could also reduce environmental waste from discarded paper.
•
Improves access to up-to-date information
Allows manufacturers to quickly update safety warnings or instructions online, ensuring users have the most current information without waiting for new paper versions to be printed and distributed.
•
Could create challenges for some users
People without reliable internet access, or those who are not comfortable with technology, might find it harder to get important safety information. While paper copies can be requested, this adds an extra step.
When does this start?
The new labeling rules would take effect once the bill becomes law, with a specific deadline for gathering public feedback.
Request for Public Comment
Not later than 2 years after the bill becomes law, the Secretary of Health and Human Services must ask for public comments on how to improve electronic labeling.