Chapter 11: FDA Unique Device Identification Verification and Validation
168 Regulatory Affairs Professionals Society (RAPS)
Examples of business rules used by the GUDID
are:
• All required data elements must be provided
• Validating specific elements (structure and
size of DI, FDA listing number, etc.)
• Data constraints on specified elements (pub-
lish date must always be ≥ TODAY) and
• System rules, which determine available user
actions based on the status of the DI record
(e.g., only unpublished and published DI
records can be copied).
When using HL7 SPL, whether using compa-
ny-developed software or a third-party solution,
the software must be verified and validated
before final DI data can be uploaded to the
GUDID. When using third-party submitters,
it is the device labeler’s legal responsibility to
ensure the third-party solution meets the records
Table 11-2. 62 Attributes for Each Device Identifier
FDA GUDID Data Fields
Labeler Regulatory Production Characteristics
Labeler DUNS Number^ Publish Date Lot/Batch Number (Y/N) Single Use (Y/N)
Company Name* Distribution End Date Manufacturing Date (Y/N) Combination Product#
Company Physical
Address*^
Distribution Status* Serial Number (Y/N) HTP/C#
Customer Contact Phone Premarket Exempt# Expiration Date (Y/N) Contains Rubber (Y/N)
Customer Contact Email Premarket Submission No. Donation ID Number (Y/N) Labeled ‘Not Made With
Rubber’#
Device Identification (DI) Supplement Number Packaging MRI Safety
Issuing Agency FDA Listing Number Device Count Size Type
Primary DI Number FDA Product Code Unit of Use DI Number Size Value
Brand Name FDA Product Code Name* Kit# Size Unit of Measure
Version/Model Number GMDN Code Package DI Number Size Type Text
Catalog Number GMDN Name* Quantity per Package Storage &Handling Type
Device Description GMDN Description* Package Contains DI
Number
S&H Low Value
Second DI Issuing
Agency
Prescription# Package Type^ S&H High Value
Secondary DI Number Over-the-Counter# Package Discontinue
Date
Storage &Handling Unit
Subject to DM, but
exempt#
Package Status* Special Storage
Conditions
DM DI Different (Y/N)# Sterile Package (Y/N)
DM DI Number Sterile Required (Y/N)
Previous DI Issuing
Agency
Sterile Method
Previous DI Number
^Data elements not released to public
*FDA GUDID System completes these fields
#Checkbox
Source: RSQM Associates LLC
168 Regulatory Affairs Professionals Society (RAPS)
Examples of business rules used by the GUDID
are:
• All required data elements must be provided
• Validating specific elements (structure and
size of DI, FDA listing number, etc.)
• Data constraints on specified elements (pub-
lish date must always be ≥ TODAY) and
• System rules, which determine available user
actions based on the status of the DI record
(e.g., only unpublished and published DI
records can be copied).
When using HL7 SPL, whether using compa-
ny-developed software or a third-party solution,
the software must be verified and validated
before final DI data can be uploaded to the
GUDID. When using third-party submitters,
it is the device labeler’s legal responsibility to
ensure the third-party solution meets the records
Table 11-2. 62 Attributes for Each Device Identifier
FDA GUDID Data Fields
Labeler Regulatory Production Characteristics
Labeler DUNS Number^ Publish Date Lot/Batch Number (Y/N) Single Use (Y/N)
Company Name* Distribution End Date Manufacturing Date (Y/N) Combination Product#
Company Physical
Address*^
Distribution Status* Serial Number (Y/N) HTP/C#
Customer Contact Phone Premarket Exempt# Expiration Date (Y/N) Contains Rubber (Y/N)
Customer Contact Email Premarket Submission No. Donation ID Number (Y/N) Labeled ‘Not Made With
Rubber’#
Device Identification (DI) Supplement Number Packaging MRI Safety
Issuing Agency FDA Listing Number Device Count Size Type
Primary DI Number FDA Product Code Unit of Use DI Number Size Value
Brand Name FDA Product Code Name* Kit# Size Unit of Measure
Version/Model Number GMDN Code Package DI Number Size Type Text
Catalog Number GMDN Name* Quantity per Package Storage &Handling Type
Device Description GMDN Description* Package Contains DI
Number
S&H Low Value
Second DI Issuing
Agency
Prescription# Package Type^ S&H High Value
Secondary DI Number Over-the-Counter# Package Discontinue
Date
Storage &Handling Unit
Subject to DM, but
exempt#
Package Status* Special Storage
Conditions
DM DI Different (Y/N)# Sterile Package (Y/N)
DM DI Number Sterile Required (Y/N)
Previous DI Issuing
Agency
Sterile Method
Previous DI Number
^Data elements not released to public
*FDA GUDID System completes these fields
#Checkbox
Source: RSQM Associates LLC