About Device Identification

UDI is a unique numeric or alphanumeric code that consists of two parts namely the Device Identifier (DI) and the Production Identifier (PI). DI is the fixed part of the UDI and is mandatory. PI is the variable part of the UDI and is conditional.

DI conta.ins information about the labeler, version number, and model number of the product. It is the static part of the UDI and it is mandatory. A labeler is mostly the device manufacturer. However, the labeler can be a:

• Specification developer
• Single-use device reprocessor
• Convenience kit assembler
• Repackager
• Relabeler

PI contains information that identifies the lot number and batch number in which the device was manufactured, serial number, expiration date, and date of manufacturing.

• Primary DI: Basic device identifier information for a medical device with UDI.
• Secondary DI: An alternate device identifier issued by a different regulatory agency.
• Unit of Use DI: A virtual device identifier for an individual medical device when UDI is not labeled on the unit of use level. This is applicable for a package that contains more than one device.
• Direct Marking DI: An identifier that is marked directly on the device.
• Package DI: An identifier for a package that contains multiple units in a base package.
• Premarket: An identifier that contains premarket regulation submission details and supplement numbers for 510(k), PMA, PDP, HDE, BLA, and NDA.
• Clinically Relevant Size: An identifier that contains medical device measurement details.
• Storage and Handling: An identifier that contains storage requirements.

The approvers are now need to be added to a device identification to complete the review process. The person or route template can be added as the approvers in the Edit mode. The following are the details about the Approvers option:

The assigned persons or route template can be updated before a route is created.

You can add a single route template to the DI.

You cannot promote the context DI to the Review state if approvers are not added.

When the DI is promoted to the Review state, a route is created either with the assigned persons or from the route template for approval.

If the approval route is not completed, because the DI is demoted, then it shows the persons who are added to the route.

A new route is not created when you promote the DI to the Review state and the status of tasks remain as the same after the DI is promoted to the Review state.

However, if a task is rejected, the route is restarted.

Route needs to be completed to promote the DI to the Approved state.

In the View mode, the task status is displayed based on the completion of the task next to to the name of the approvers.

FDA has also created a Global Unique Identification Database (GUDID) to store basic information about each device that has a UDI. The UDI or the GUDID will not store information about the person or organization that uses the device.

Health care professionals, regulators, and patients can access the GUDID and search for information about a device. The GUDID stores only DI information and not PI information. However, it contains PI flags to specify the details that must appear on the device label.

According to the FDA regulation on UDI, the labeler must submit device identification to the GUDID. The labeler must obtain a GUDID account to submit information. A GUDID account is not required to search the GUDID.

DI submitted to the GUDID must be unique. An existing DI cannot be reused even if the product is not distributed anymore. Package information for a specific version or model of a device is included with the DI details.

The lifecycle of a device identification object consists of the following states.

• Draft: When you create a device identification object, it is created in the Draft state. In this state, you can clone, transfer, modify, or delete the device identification object, create a summary report, and promote the device identification object to the Review state.
• Review: In this state, you can clone, transfer, modify, or delete the device identification object, create summary report, and promote the device identification object to the Approved state. However, to promote the device identification object to the Approved state, you must provide information in all the mandatory fields in the Device Information page, Device Status page, and the Device Characteristics page.
• Approved: In this state, you can clone the device identification object and create summary report. A Regulatory Lead can submit the device identification object to the regulatory authority. To promote the DI that is created in the EU region to the Approved state, the following validations need to be completed:
  • The connected product identification needs to be validated.
  • The Product Identfier is required with the value as Software Indication for the approval process.
  • The Published Date field is optional for other authorities except USA. However, if provided it is used for the Device Substatus applicability as per the business rule.
  • The Contact ID field is mandatory for the Contact Type as Manufacturer and Authorized Representative.
• Submitted: The device identification object moved to this state after it is submitted to the regulatory authority. In this state, you can demote the device identification object to the Approved state.
• Published: When the acknowledgment received from the regulatory authority indicates that the submission is successful, the device identification object is moved to this state.