Medical Device Electronic Labeling Act

Bill Number

S. 4519

Origin Chamber

Senate

Congress

119th Congress, Session 2

Status

Introduced

Latest Action

2026-05-13: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Last Updated

2026-05-19T00:53:28Z

AI-Generated Summary

Purpose The legislation amends the Federal Food, Drug, and Cosmetic Act to permit manufacturers to provide required labeling for medical devices solely through electronic means, while maintaining safeguards for user access and safety.

Key Provisions

• Amends Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) to allow electronic labeling for devices, including in vitro diagnostic devices, under specific conditions.
• Requires that electronic labeling be user-friendly, comply with all applicable laws, and include a mechanism for users to request and receive a free paper copy promptly.
• Mandates that the physical label on the device or its immediate container still contain required information in compliance with the Act and any relevant regulations or orders.
• Authorizes the Secretary of Health and Human Services to issue orders establishing additional requirements or exceptions to the electronic labeling rules, with publication in the Federal Register and opportunity for public comment.
• Directs the Secretary, acting through the Food and Drug Administration Commissioner, to issue a request for information and open a public docket within two years to gather input on improving the format and usability of electronic labeling for certain non-prescription devices and in vitro diagnostics.

Significant Changes to Existing Law This bill expands the allowance for electronic-only labeling of devices, which was previously more restricted under the Federal Food, Drug, and Cosmetic Act. It introduces a structured framework with user protections and regulatory flexibility via orders, replacing stricter physical labeling mandates for qualifying devices.

Potential Impacts

• On government agencies: Increases the Food and Drug Administration's role in reviewing and ordering device-specific labeling rules while requiring public input processes.
• On citizens: Provides easier electronic access to device information for users, with a guaranteed option for paper copies to address accessibility needs.
• On international relations: No direct effects are outlined in the legislation.

Main Stakeholders Affected

• Medical device manufacturers, who gain flexibility in labeling delivery.
• The Food and Drug Administration, responsible for oversight and issuing orders.
• Healthcare professionals and facilities, as well as patients and other end users of devices.
• Blood establishments and operators of in vitro diagnostic devices.

Notable Legal, Constitutional, or Political Implications The bill includes provisions for public dockets and Federal Register publication to support transparency in regulatory orders. It emphasizes maintaining reasonable assurance of device safety and effectiveness, with exceptions possible if electronic labeling alone is deemed insufficient. No major constitutional issues are addressed in the text.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Banks, Jim [R-IN]

Cosponsors (1)

Sen. Hickenlooper, John W. [D-CO]

Recent Actions

• 2026-05-13: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
• 2026-05-13: Introduced in Senate

Bill Versions

• Medical Device Electronic Labeling Act — issued 2026-05-13 — PDF (5 pages)