Bill > HR1539

This bill modifies the Federal Food, Drug, and Cosmetic Act to allow medical device manufacturers to provide required product labeling exclusively through electronic means, with important safeguards. Under the new provisions, electronic labeling would be permitted only if the labeling is readily accessible to intended users, manufacturers offer a way for users to request paper copies of the labeling at no additional cost, and the physical device label still includes all legally required information. The U.S. Food and Drug Administration (FDA) would have the authority to establish additional requirements or exceptions for electronic labeling through a formal rulemaking process, ensuring that any such changes are made transparently and only when necessary to maintain device safety and effectiveness. The bill applies to various medical devices, including in vitro diagnostic devices, and aims to modernize labeling practices by allowing more flexible, digital information distribution while still protecting consumer access to critical product information.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/1539/all-info