HR 1539

This bill, the Medical Device Electronic Labeling Act, would allow medical device manufacturers to provide directions for use and warnings electronically instead of on physical labels. Currently, electronic labeling is limited to prescription devices in healthcare settings and in vitro diagnostic devices. The bill expands this to all medical devices, as long as users can easily access the electronic information, can request a paper copy at no cost, and the physical label still contains all required information. The FDA would have the authority to create additional rules and exceptions.