Medical Device Electronic Labeling Act
The Medical Device Electronic Labeling Act would amend the Federal Food, Drug, and Cosmetic Act to allow certain medical device labels (including in vitro diagnostic devices) to be made available primarily through electronic means rather than only in printed form. The bill requires that electronic labeling be readily accessible to intended users and that manufacturers provide a free, on-demand paper copy of the labeling upon request. The physical label on the device or its immediate container must still include all required information. The Secretary (FDA) could issue additional labeling requirements or exemptions for specific device types through formal orders published in the Federal Register after a public comment process. Overall, the bill aims to modernize labeling by increasing use of digital labeling while preserving access to printed information upon request.
Key Points
- 1Allows required device labeling to be made available solely by electronic means, including in vitro diagnostic devices, with conditions:
- 2- (A) labeling must be readily accessible to intended users;
- 3- (B) manufacturers must provide a paper copy of the labeling to any user who requests it, at no additional cost;
- 4- (C) the label on the device or its immediate container must include all information required by the Act and applicable regulations or orders.
- 5Paper copies on request: Even when labeling is electronic, users can request and receive a printed version at no extra charge.
- 6Secretary’s authority to regulate labeling further: The Secretary may issue orders that add to or carve out exceptions from labeling requirements for specific device types, detailing what must be included on the device label or what conditions apply.
- 7Process for new labeling orders: Any such orders must be published in the Federal Register after a proposed order and public docket/comment period, ensuring transparency and public input.
- 8Safety and effectiveness standard preserved: Any added labeling requirements or conditions through orders must be necessary to provide reasonable assurance of a device’s safety and effectiveness.