Medical Device Electronic Labeling Act

Electronic Accessibility: Required labeling for devices, including in vitro diagnostic devices, may be made available solely by electronic means, provided it is readily accessible to intended users (Section 2, subparagraph (2)(A)).

Consumer Choice for Paper Documentation: Manufacturers are required to provide the opportunity for intended users to request required labeling in paper form, which must be provided promptly and without additional cost (Section 2, subparagraph (2)(B)).

Safety Oversight: The Secretary has the authority to issue orders that require device labels to contain specific information or follow certain conditions to ensure a reasonable assurance of the safety and effectiveness of the device (Section 2, subparagraph (3)(C)).

Potential Lack of Physical Labeling: The bill allows required labeling to be made available solely by electronic means, meaning a device or its container may not have all the required information physically attached (Section 2, subparagraph (2)).

Requirement for Manual Requests: Because the bill allows for labeling to be solely electronic, users may need to take the extra step of requesting paper information from the manufacturer if they cannot or do not wish to use electronic formats (Section 2, subparagraph (2)(B)).