Medical Device Electronic Labeling Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow required labeling for medical devices (including in vitro diagnostic devices) to be provided solely by electronic means, under certain conditions. It also requires the Secretary of Health and Human Services to seek public input on optimizing electronic labeling for certain devices.

Sec. 2, Allowing required labeling of devices to be made available solely by electronic means: This section replaces current labeling requirements to permit electronic-only labeling for devices, provided that the labeling complies with all legal requirements, the manufacturer gives intended users easy access to it, and users can request a paper copy at no extra cost. The label on the device or its container must still include all required information. The Secretary may issue orders adding extra requirements or exceptions to these electronic labeling rules, with specific justifications and public notice.

Sec. 3, Request for information and public comment: Within two years of the bill's enactment, the Secretary of Health and Human Services, through the FDA Commissioner, must publish a request for information in the Federal Register and on a public HHS website, creating a public docket for stakeholders to comment on improving the format, accessibility, and usability of electronic labeling for devices that are not prescription devices for health care settings or in vitro diagnostic devices for professionals.