Medical Device Electronic Labeling Act

# Medical Device Electronic Labeling Act (HR 1539) - Summary **What the bill does:** This bill would expand when manufacturers can provide medical device instructions and warning labels electronically instead of printing them on the device or its packaging. Currently, only prescription devices used in hospitals and certain lab devices can use electronic labeling. The bill would extend this to virtually all medical devices, as long as the electronic labels are easily accessible to users and patients can request printed copies for free. **Who it affects:** Patients using medical devices, healthcare facilities, medical device manufacturers, and regulators.

The change could reduce packaging waste and production costs for manufacturers while requiring companies to ensure electronic labels remain available and accessible to users. **Key provisions:** Electronic labels would be allowed for all medical devices if: (1) the information is readily available to users electronically, (2) patients/users can request paper copies at no cost, and (3) the physical device packaging still contains certain required information. The bill maintains safety requirements while modernizing how labeling can be delivered. **Current status:** The bill is in committee (as of the 119th Congress) and has not yet been voted on by the full House.