Medical Device Electronic Labeling Act

This bill lets makers of all medical devices put required directions and warning labels online instead of only on paper. The electronic label must be easy for the intended users to find, and anyone can ask for a free paper copy. The device’s package label still has to include all information required by existing law. The FDA can set extra rules or exceptions if needed for safety and effectiveness, after taking public comments.

Key points

• Who is affected: People who use medical devices at home or in health care settings, and device makers.
• What changes: Directions and warnings may be provided only electronically for all device types, including in vitro diagnostic devices, as long as users can easily access them and can request free paper copies; package labels must still meet current requirements.
• Oversight: FDA may issue orders adding requirements or allowing exceptions to keep devices safe and effective, with notice and a chance for public comment.