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Data Elements Reference Table(DERT) Updates

April 24, 2018Heather Valadez and Grace Kim

US FDA Informatics Staff

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Data Element UpdatesWhy?

For clarification

For adoption

For data quality

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Latest Updates• Description and Data Entry Notes clarified for many data

elements• New Header note added• New Footnote added• New Publicly released data elements added• New sheets added• Changelog sheet has been updated with all the changes

NEW

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• Please check your data for accuracy and completeness

• Enter English alphabet characters• No special characters except for and• No double quotes “ ”

General Notes

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According to 830.330(b), The labeler of a device shall submit to FDA an update to the information required by § 830.310 whenever the information changes. The updated information must be submitted no later than the date a device is first labeled with the changed information. If the information does not appear on the label of a device, the updated information must be submitted within 10 business days of the change.

Header Note

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New Data Elements

Public VersioningPublic Device Record Key*Public Version Number*Public Version Date*Public Version Status

* Added March 30, 2018

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Acronyms sheet

• Acronyms previously listed under footnote 5 are now in a new sheet

• The list of acronyms has been expanded

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List of Values (LOV) sheet• Moved LOVs from the Entry List of Values column to its own sheet

Size typeSize values unit of measureSterilization methodStorage and handling typeStorage and handling unit of measureMRI safety

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Sample Label sheet

Fictitious Medical Device Label

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Helpful Links sheet

• FDA UDI main page• FDA UDI Help Desk• AccessGUDID• OpenFDA and others . . .

Links to helpful UDI resources

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ONC EHR 2015 certification regulation for UDI added to Footnote 6

Data elements required in the implantable device list as part of electronic health records per the ONC 2015 edition Health IT certification criteria regulation 45 CFR 170.315(a)(14). The data elements are primary DI, brand name, model/version, company name, MR safety, Latex, Description (GMDN/SNOMED), and Production Identifiers (Lot, serial number, expiration date, manufacture date, and DIC (see Donation Identification Number data element).https://www.healthit.gov/sites/default/files/2015Ed_CCG_a14-Implantable-device-list.pdf

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Primary DI

Clarified Description and Data Entry Note• The Primary DI is the DI portion of the UDI placed on the

lowest package level of a device that is required to meet UDI label requirements

• If the device is not packaged, the UDI may be on the device itself, thereby satisfying both the UDI label and the direct mark requirement if the UDI is intended to be permanent.

Added to Data entry note• Ensure the check digit/character is correct and valid per

issuing agency guidelines

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OR

IF Device is NOT PackagedPrimary DI = DI on the device itself,

could be Direct Mark (DM) DI

Primary DIAdded to Data Entry NoteIF Device IS Packaged

Primary DI = DI portion of the UDI on the lowest package level

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Direct Mark DI & DM DI Different from Primary DI

IF Device IS Packaged AND DM DI = Primary DI on device labelTHEN

Do not enter DM DIELSE IF DM DI ≠ Primary DI on device labelTHEN

Enter DM DI

Clarified the Description and Data Entry Note

IF Device IS NOT PackagedAND DI permanently marked on the device (i.e., DM DI)AND DM DI = Primary DI

THEN Do not enter DM DI; DM DI is the Primary DI

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Brand NameDescription• A trade/proprietary name assigned by the device labeler and

under which the device is sold, distinguished from other similar devices, and recognized by the user or purchaser.

Data entry note• If there is no brand name for your device then enter the name

commonly used to refer to the device or family of devices. • Name should be greater than one character in length.• Do not enter NA, N/A, Not Applicable or any other similar term.

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Catalog Number

Required in database columnOptional Recommended - Critical for identification and adoptionData entry note• Use the catalog, reference, reorder or product number on the device label.• If there is no catalog, reference, reorder or product number use the

number reported in a business/clinical transaction or that would be reported in case of a recall or adverse event.

• Currently 60% records with catalog number

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Device Description

Required in database columnOptional Recommended - Critical for identification and adoption

Data entry note• URL can be included but it is to supplement and needs to be kept up

to date• Currently 76% records with description

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Commercial Distribution End Date

Data entry note• Do not populate this field for deactivating/deleting

records. Please contact the FDA UDI Help Desk.

• If you do not know an exact commercial distribution end date, please do not populate an estimated date.

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Product CodeDescription• Categorization for devices used by the FDA.Data entry note• For all PMA, 510(k), HDE and De Novo devices, product codes are

assigned in the FDA approval, clearance or classification letter, respectively.

• For most De Novo devices, the product code can be found in the reclassification order.

• If the product code is down classified then use the same product code that was used to register and list the device.

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Clinically Relevant Size• Size Type and Size Values Unit of Measures lists have moved to

the LOV sheet• If you do not see your size type in the List of Values (LOV), then

submit your suggestion for review as a new LOV via FDA UDI Help Desk. Submit with a subject line List of Values. Include the GMDN term(s) that the LOV is pertinent to.

• Additional size types and units of measure will be added to the drop down list in the future

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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

Data entry noteIF Issuing Agency = ICCBBA,

DIC = DINElse IF Issuing Agency = GS1 or HIBCC then DIC = Serial Number

OR DIC = Lot NumberOR DIC = Serial + Lot Number

Donation Identification Number (DIN)

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FDA Premarket Submission Number Supplement Number

We are planning to release this data element in the near future.

Labeler DUNS NumberChanged No to Yes

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Kits

• Clarification to kits will be coming in the near future

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Discussion and Questions

GUDID Data Elements Reference Table Link