S.4519

Medical Device Electronic Labeling Act allows electronic-only labeling for certain devices.

The Medical Device Electronic Labeling Act amends the Federal Food, Drug, and Cosmetic Act to allow required labeling for devices to be made available solely by electronic means. This applies to devices intended for use by patients without provider supervision, provided the labeling complies with all applicable requirements and users can easily access it. The manufacturer must also offer the option to request paper form labeling without additional cost. The Secretary of Health and Human Services can issue orders establishing additional requirements or exceptions for electronic labeling.