Data Elements Reference Table (DERT) Updates

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1 Data Elements Reference Table (DERT) Updates April 24, 2018 Heather Valadez and Grace Kim US FDA Informatics Staff Slide 1

2 Data Element Updates Why? For clarification For adoption For data quality Slide 2

3 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 NEW Changelog sheet has been updated with all the changes Slide 3

4 Please check your data for accuracy and completeness Enter English alphabet characters No special characters except for No double quotes General Notes and Slide 4

5 Header Note According to (b), The labeler of a device shall submit to FDA an update to the information required by 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. Slide 5

6 New Data Elements Public Versioning Public Device Record Key* Public Version Number* Public Version Date* Public Version Status * Added March 30, 2018 Slide 6

7 Acronyms sheet Acronyms previously listed under footnote 5 are now in a new sheet The list of acronyms has been expanded Slide 7

8 List of Values (LOV) sheet Moved LOVs from the Entry List of Values column to its own sheet Size type Size values unit of measure Sterilization method Storage and handling type Storage and handling unit of measure MRI safety Slide 8

9 Sample Label sheet Fictitious Medical Device Label Slide 9

10 Helpful Links sheet Links to helpful UDI resources FDA UDI main page FDA UDI Help Desk AccessGUDID OpenFDA and others... Slide 10

11 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 (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). Slide 11

12 Primary DI Added to Data entry note Ensure the check digit/character is correct and valid per issuing agency guidelines 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. Slide 12

13 OR Primary DI Added to Data Entry Note IF Device IS Packaged Primary DI = DI portion of the UDI on the lowest package level IF Device is NOT Packaged Primary DI = DI on the device itself, could be Direct Mark (DM) DI Slide 13

14 Direct Mark DI & DM DI Different from Primary DI Clarified the Description and Data Entry Note IF Device IS Packaged AND DM DI = Primary DI on device label THEN Do not enter DM DI ELSE IF DM DI Primary DI on device label THEN Enter DM DI IF Device IS NOT Packaged AND 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 Slide 14

15 Brand Name Description 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. Slide 15

16 Catalog Number Required in database column Optional Recommended - Critical for identification and adoption Data 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 Slide 16

17 Device Description Required in database column Optional 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 Slide 17

18 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. Slide 18

19 Product Code Description 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. Slide 19

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

20 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 Slide 20

21 Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) Donation Identification Number (DIN) Data entry note IF Issuing Agency = ICCBBA, DIC = DIN Else IF Issuing Agency = GS1 or HIBCC then DIC = Serial Number OR DIC = Lot Number OR DIC = Serial + Lot Number Slide 21

22 Labeler DUNS Number Changed No to Yes FDA Premarket Submission Number Supplement Number We are planning to release this data element in the near future. Slide 22

23 Kits Clarification to kits will be coming in the near future Slide 23

24 Discussion and Questions GUDID Data Elements Reference Table Link Slide 24

UDI Requirements and Resources

UDI Requirements and Resources Bryan Love Supervisory Consumer Safety Officer Denver District Annual RMRAS January 2016 UDI Specific Legal Milestones 2007 FDAAA the system 2012 FDASIA the timelines 2013