H.R. 1539 — Medical Device Electronic Labeling Act

This section revises the misbranding provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning adequate directions for use and warnings to authorize required labeling for devices (including in vitro diagnostic devices) to be made available solely by electronic means, provided that (1) such labeling is readily accessible to intended users, (2) the manufacturer offers intended users the opportunity to request the labeling in paper form and promptly provides it without additional cost, and (3) the label affixed to the device or its immediate container complies with the FD&C Act, FDA regulations, or any applicable Secretary order. The section further authorizes the Secretary to issue orders—published in the Federal Register following a proposed order and public comment—imposing additional requirements or exceptions on such affixed labels only if necessary to provide reasonable assurance of the device's safety and effectiveness.