GUDID MRI and latex information: map label statements without inventing claims
Use the actual device labelling to prepare MRI and latex information. FDA’s acquired table says the MRI field submits information the labeler already possesses and does not itself require MRI compatibility testing. The latex fields have different conditions; the optional “not made with” field is not a general declaration that all unmarked products are latex free.
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.
Field
Recorded entry condition
Post-grace-period edit rule
Recorded new-DI trigger
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437). [1]
Required
None
Yes
Device labeled as "Not made with natural rubber latex" [2]
Optional
If no data is provided, "No" is stored
Add
Delete
Edit
No
What MRI safety information does the labeling contain? [3]
Required
Edit*
*ONLY if changing from 'Labeling does not contain…' to other MR status (Safe, Unsafe, Conditional). Otherwise, NO changes are allowed.
Yes
Definitions and entry notes
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437). [1]
Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. Choosing 'Yes' indicates that the device label or packaging contains one of the following statements: (1) "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions", (2) This Product Contains Dry Natural Rubber", (3) Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" or (4) "The Packaging of This Product Contains Dry Natural Rubber".
Recorded entry notes and format
Choose Yes/No from the drop down list.
Data type: Type: Boolean
Entry values: Yes/No
Device labeled as "Not made with natural rubber latex" [2]
Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information. Only applicable to devices not subject to the requirements under 21 CFR 801.437. Not all medical products that are NOT made with natural rubber latex will be marked.
Recorded entry notes and format
Select checkbox if appropriate.
Only applicable if the response to "Device required to be labeled as containing natural rubber latex or dry natural rubber" is "No".
Optional element for labelers who include a statement of 'latex-free' on their label or in their labeling. FDA finds these statements: 'latex-free' and 'does not contain latex', to be not scientifically supportable and strongly recommends they not be used in medical product labeling. Instead FDA recommends the use of the statement 'Not made with natural rubber latex."
It is not assumed that all devices NOT made with natural rubber latex are marked; therefore this is an optional element for the labelers who choose to make a statement in the labeling.
Data type: Type: Boolean
Entry values: NA
What MRI safety information does the labeling contain? [3]
Indicates the MRI Safety Information, if any, that is present in the device labeling. Please see the ASTM F2503-13 standard for more information.
Recorded entry notes and format
Choose a value from the drop down LOV.
The final rule does not require MRI-compatibility testing; it only requires submission of information regarding MRI-compatibility that the labeler already possesses.
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.
Collect approved statements
Retain the exact MRI information and any applicable natural-rubber statement from the controlled labelling.
Useful evidence: Approved label/IFU and supporting statement rationale.
Review the conditional choices
Compare the MRI and latex entry/edit conditions independently; preserve “no information” and unmarked cases without creating safety claims.
Useful evidence: Statement-to-field comparison and unresolved condition list.
Escalate changes to evidence owners
Have the responsible specialist assess any new or changed safety statement before changing public data; the upload service cannot create validation evidence.
Useful evidence: Change-control record and separate evidence-review scope if needed.
Work packages and dependencies
Conditional: GUDID MRI and latex information: map label statements without inventing claims — 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 controlled label statements will you use for these fields?
How will you handle unmarked products or no MRI information without inventing a claim?
Who reviews an MRI/latex statement change and its supporting evidence?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
