Medical Device Electronic Labeling Act

The Medical Device Electronic Labeling Act allows manufacturers to provide required labels for medical devices solely through electronic means, provided users have easy access to this information. To ensure safety, the law requires that manufacturers offer a free, easy way for users to request paper copies of labels and mandates that the physical device or its container still displays all necessary compliance information. The FDA retains the authority to issue specific orders requiring additional physical labeling or exempting certain devices if electronic-only labels are deemed unsafe for unsupervised patient use. Additionally, the bill directs the FDA to gather public feedback within two years on how to improve the format and usability of these electronic labels for non-prescription devices.