Medical Device Electronic Labeling Act

This bill would change federal food and drug law so that required labeling for medical devices, including in vitro diagnostic devices, could be provided only in electronic form. Manufacturers using electronic-only labeling would have to give users easy access to it and provide a paper copy promptly and at no extra cost when requested. The label attached to the device or its container would still have to include all legally required information. The Secretary of Health and Human Services could issue orders adding requirements or granting exceptions, after public notice and comment, and within 2 years would have to seek public comments on electronic labeling for certain devices.

Full text and official record on Congress.gov

Sponsors

• Jim Banks Republican sponsor
• 1 cosponsors