Summary

Allows medical device makers to provide required labeling only in electronic form if users can easily access it. This includes in vitro diagnostic devices. A free paper copy must be provided on request, and on‑device or container labels must still carry required core information, with the option for the Secretary to require additional items. The Secretary can set device‑specific labeling rules by order after a public comment period and will publish final orders in the Federal Register. The goal is to modernize labeling, speed updates, reduce printing burdens, and keep information accessible to clinicians and patients who need paper copies.

Key Points

• Allows electronic-only labeling for medical devices, including IVDs, if users can readily access it.
• Manufacturers must provide free paper copies of labeling upon request.
• Physical device/container labels must continue to include required core information.
• The Secretary can require additional items to appear on physical labels for certain devices.
• The Secretary may set device-type-specific labeling rules via public order after notice and comment.
• Orders must be published in the Federal Register following a public comment process.
• Improves flexibility and speed of labeling updates while preserving access for offline users.
• No new spending, taxes, or state/local mandates are created.

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