Medical Device Electronic Labeling Act
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the types of devices for which required labeling may be made available solely by electronic means. It replaces language restricting this practice to prescription devices in health care facilities and certain in vitro diagnostic devices with a broader category of devices (including in vitro diagnostic devices).
Key points
Allows required labeling to be made available solely by electronic means for devices, including in vitro diagnostic devices.
Removes previous restrictions that limited electronic labeling primarily to prescription devices intended for use in health care facilities or by health care professionals.
Expired
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