A bill to amend the Federal Food, Drug, and Cosmetic Act to expand the types of devices for which required labeling may be made available solely by electronic means, and for other purposes.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 4519 Introduced in Senate (IS)] <DOC> 119th CONGRESS 2d Session S. 4519 To amend the Federal Food, Drug, and Cosmetic Act to expand the types of devices for which required labeling may be made available solely by electronic means, and for other purposes. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES May 13, 2026 Mr. Banks (for himself and Mr. Hickenlooper) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ A BILL To amend the Federal Food, Drug, and Cosmetic Act to expand the types of devices for which required labeling may be made available solely by electronic means, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Medical Device Electronic Labeling Act''. SEC. 2. ALLOWING REQUIRED LABELING OF DEVICES TO BE MADE AVAILABLE SOLELY BY ELECTRONIC MEANS. Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended to read as follows: ``(f)(1) Unless its labeling bears (A) adequate directions for use; and (B) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (A) of this subparagraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement. ``(2) Subject to subparagraph (3), required labeling for devices (including in vitr