GUDID publication and distribution-end dates: separate device and package status
The acquired field reference distinguishes DI record publication, the device’s commercial-distribution end date and the higher package’s discontinue date. Some statuses are system populated. Prepare a dated device/package change plan instead of treating a public version update as proof that a device is currently sold or authorised.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Observed FDA field relationships
Which fields change this workflow?
FDA Data Elements Reference Table; acquired link labelled December 17, 2024. Entry conditions and edit rules below are transcribed from that version.
This date determines when a record would be publicly available on AccessGUDID.NLM.NIH.gov and OpenFDA.gov. The GUDID system adds the Grace Period (7 calendar days) to the DI Record Publish Date to calculate the public release date.
Recorded entry notes and format
Choose a date from calendar or manually enter date in format yyyy-mm-dd.
An example for the calculation of when a record would be available publicly: if March 15, 2020, is entered for DI Record Publish Date, the record will display publicly on March 23, 2020. (Note: the public sites are updated on business days. If the calculated date falls on a weekend, data will display on the Monday after that weekend.)
Some data elements are not allowed to be edited after the record is made available publicly (review Edit Rules after Grace Period column). We recommend you set this date to allow time to review and ensure accurate data entry.
Data type: Type: Date Format (yyyy-mm-dd)
Length: 10
Indicates the date the device is no longer offered for commercial distribution by the labeler on record. See 21 CFR 807.3(b) for exceptions. The device may or may not still be available for purchase in the marketplace.
Recorded entry notes and format
Choose date from calendar or manually enter date in format yyyy-mm-dd.
Do not populate this field for deactivating/deleting records. Please contact the FDA UDI Help Desk at FDA UDI Help Desk.
If you do not know an exact commercial distribution end date, please do not populate an estimated date.
Data type: Type: Date Format (yyyy-mm-dd)
Length: 10
Indicates whether the device is in commercial distribution as defined under 21 CFR 807.3(b).
Recorded entry notes and format
Auto populated based on Commercial Distribution End Date. If no Commercial Distribution End Date is entered, the status is 'In Commercial Distribution'
Data type: NA
Entry values: In Commercial Distribution; Not in Commercial Distribution
Indicates the date this particular package configuration is discontinued by the labeler.
Recorded entry notes and format
Choose date from calendar or manually enter in format yyyy-mm-dd.
Discontinuation of a package is directly related to the discontinuation of the primary DI of the base package. However, a package can also be discontinued without the discontinuation of the base package.
Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b).
Recorded entry notes and format
Auto populated based on Package Discontinue Date. If Package DI and related elements are entered and no Package Distribution End Date is entered, the status is 'In Commercial Distribution.'
Data type: NA
Entry values: In Commercial Distribution; Not in Commercial Distribution
Reference limits and edit-rule footnotes
Add = Addition of new data is allowed; Delete = Deletion of entered data is allowed; Edit = Editing of entered data is allowed; None = NO edit, add, or delete are allowed; NA = data element is not able to be changed directly; most are ‘auto-populated’ fields whose information depends on another data element
Note: The above do not apply if the device is “unlocked” for editing. For more information on “unlocking” device records for editing, please visit www.fda.gov/udi [6]
See 21 CFR 830.310 and 830.340 for required data elements. [7]
Most of the information presented here is applicable to GUDID HL7 SPL submissions, but there are some differences pertinent to each submission option. Please refer to the HL7 SPL Implementation package of files for additional details on HL7 SPL xml file submission option. [8]
These are dated FDA reference-table fields, not an automated legal applicability assessment or validated submission. The AccessGUDID download schema is different from the FDA HL7 SPL submission implementation package. No quarantined schema is used.
A mapping worksheet for this workflow
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Assign the right date to the right event
Separate intended public release, device distribution end and package discontinuation using the controlled operational records.
Useful evidence: Release plan and dated distribution/package decisions.
Review related records together
Check affected package DIs when device distribution-end data changes; identify which reference fields are conditional and which are system populated.
Useful evidence: Device-to-package inventory and change matrix.
Reconcile after release
Check the published device and supporting package records against the planned events; escalate differences without inferring sales or approval from status.
Useful evidence: Post-release reconciliation and unresolved exceptions.
Work packages and dependencies
Conditional: GUDID publication and distribution-end dates: separate device and package status — Review the controlled source evidence, prepare the field/relationship mapping described here, resolve exceptions and reconcile the intended records before confirming submission scope.
Questions for providers
Which dates do you request for the device and each affected package?
How will you validate the system-populated statuses after submission?
How do you retain and reconcile historic distribution records?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
