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Under the proposed unique device identification (UDI) system, the lot or batch number, serial number, expiration or manufacture date, and information about the model and labeler must be marked in both plain text and via a bar code on the label of most medical devices. Most of that information will also be included in a publicly accessible database to be created by FDA.
Implantable devices, devices meant for multiple use, devices that must be sterilized before each use, and standalone software must contain the required information on the device itself rather than on the label. Class I and over-the-counter devices would not be required to include UDI.
According to the proposed rule, the system is intended to reduce errors due to misuse of devices, allow for more accurate reporting of adverse affects from medical devices, improve recalls of products, and standardize dates listed on medical device labels.
The proposed rule comes nearly five years after Congress passed the Food and Drug Administration Amendments Act of 2007, which called for creation of a UDI system.
The agency is seeking comments on the proposed rule for 120 days after its publication in the Federal Register.