Medical Device Electronic Labeling Act

The "Medical Device Electronic Labeling Act" proposes to amend the Federal Food, Drug, and Cosmetic Act, specifically Section 502(f), to expand the types of medical devices for which required labeling may be made available solely by electronic means. This change applies to all devices, including in vitro diagnostic devices, provided that the electronic labeling is readily accessible to their intended users. A key provision mandates that manufacturers must afford intended users the opportunity to request the required labeling in paper form, and upon such a request, must promptly provide the information without any additional cost. Additionally, the physical label affixed to the device or its immediate container must still comply with all existing regulations and any applicable orders issued by the Secretary. The Secretary of Health and Human Services is granted authority to issue orders establishing further requirements or exceptions for electronic labeling, but only if deemed necessary to provide a reasonable assurance of the device's safety and effectiveness.