GUDID sterile packaging versus sterilization before use: keep the fields separate
The acquired FDA reference explicitly treats “Device Packaged as Sterile” and “Requires Sterilization Prior to Use” as independent questions. A prior-to-use “Yes” activates a sterilization-method condition. These fields describe the supplied device and user instructions; they do not document a validated manufacturer sterilization process or select a new process.
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.
Indicates the medical device is free from viable microorganisms. See ISO/TS 11139.
Recorded entry notes and format
Choose Yes/No from the drop down list. If all constituents within a kit including the kit itself as packaged is sterile then choose Yes. Otherwise choose No.
The two Sterilization Method questions are independent of each other; this element is designed to capture information about the device as it enters Commercial Distribution. These data elements are not designed to capture sterilization procedures executed by the manufacturer or labeler.
Indicates that the device requires sterilization prior to use.
Recorded entry notes and format
Choose Yes/No from the drop down list.
The two Sterilization Method questions are independent of each other; this element is designed to capture information about the device before it can safely encounter a patient, regardless of whether the device is single use or reused after reprocessing. These data elements are not designed to capture sterilization procedures executed by the manufacturer or labeler.
If answered 'Yes', at least one Sterilization Method (below) must be selected.
Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient.
Recorded entry notes and format
Choose a value from the drop down LOV.
Only applicable if the answer to 'Requires Sterilization Prior to Use' is 'Yes'; otherwise, the LOV will remain inactive.
Note that the sterilization method must be applied by the user prior to device use on patient.
The Entry LOVs represent the sterilization methods recognized by the CDRH Infection Control Branch. Methods selected should be only those approved for each device by the CDRH Office of Device Evaluation.
Data type: NA
Entry values: Refer to List of Values (LOV) sheet
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 [4]
See 21 CFR 830.310 and 830.340 for required data elements. [5]
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. [6]
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.
Confirm the supplied-device state
Check the controlled packaging/label evidence for the device or kit as supplied, including the stated kit condition.
Useful evidence: Approved labels, packaging specification and kit constituent information.
Review the user’s instructions
Separately identify whether sterilization is required before use and the documented method(s) applicable to that device.
Useful evidence: Approved IFU/reprocessing instructions and controlled method references.
Separate data preparation from validation
Have the specialist resolve label/IFU disagreements and any underlying validation gaps; mapping a field cannot validate a method.
Useful evidence: Reconciliation report and a separately scoped validation question if evidence is missing.
Work packages and dependencies
Conditional: GUDID sterile packaging versus sterilization before use: keep the fields separate — 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
How will you reconcile the two independent sterility questions?
Which approved IFU evidence supports each prior-to-use method?
Will your quotation separate data mapping from any required validation investigation?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
