Congress·In Committee·S. 4519

Medical Device Electronic Labeling Act

Medical Devices: Digital Instructions and Labeling

May 13·View on Congress.gov·Read full text

This bill is one vehicle in a longer effort. See the full story across every version.View effort →

Next up: A senate committee

This bill is currently in the early stages of the legislative process after being sent to the Senate Committee on Health, Education, Labor, and Pensions for review. It is actively moving through the system, but no future hearings or votes have been scheduled yet. There is no companion bill listed for this proposal at this time.

Legislative Progress

Senate

House

President

Law

Could go either way

The bill has support from both parties, which is a good sign, but it is still in the very early stages of the lawmaking process.

How we got here

This bill’s path across every version that has carried it.

Reintroduced
Reintroduced from H.R. 3723 (118th), which died when its Congress ended.
H.R. 3723 (118th) →

Key Points

This bill lets companies that make medical devices provide instructions and safety warnings online instead of printing them on paper. This would apply to many types of equipment, including tools used in hospitals and some devices used at home.
Manufacturers must make sure the digital information is easy for people to access. If a user still wants a paper version, the company must provide it quickly and for free.
The government can still require paper labels if they decide a device is too risky to use without physical instructions. This is mostly for devices that people use on their own without a doctor watching them.
Within two years of the bill becoming law, health officials will ask the public for ideas on how to make digital labels easier to read and use. This helps ensure the technology works well for everyone.

Impact Analysis

Govbase has not yet run an impact analysis on this legislation.

Milestones

2 milestones2 actions

May 13, 2026Senate

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.

May 13, 2026

Introduced in Senate

The bill was officially filed and given a number. It now enters the legislative queue.

No votes, news coverage, or related bills recorded for this bill yet.

Source Information

Document Type

Congressional Bill

Official Title

Medical Device Electronic Labeling Act

Bill NumberS 4519

Congress119th Congress

ChamberSenate

Latest ActionRead twice and referred to the Committee on Health, Education, Labor, and Pensions.

Data Sources

Congress.gov

Official legislative information

Read Full Bill Text

Sponsor

Cosponsors

(1)

D: 1

Analysis generated by AI. Always verify with official sources.