Centers for Devices and Radiological Health (CDRH) Global Unique Device Identififer Database (GUDID) Terminology Files

The CDRH-GUDID-NCIt terminology files provided here support the cooperative efforts of the Centers for Devices and Radiological Health (CDRH) Unique Device Identifcation (UDI) Program and the National Cancer Institute's Thesaurus (NCIt). Within the UDI Rule, FDA has the authority to require submission of key device attributes, along with the device identifier (DI) to the GUDID. All GUDID attributes and lists of values can be found in the CDRH-GUDID-NCIt terminology files.

CDRH-GUDID terminology files are available for download from this NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/CDRH/GUDID) in three formats:

FDA-CDRH-GUDID_NCIt_Subsets.xls (Microsoft Excel 2003)*
FDA-CDRH-GUDID_NCIt_Subsets.txt (Tab-delimited text)
FDA-CDRH-GUDID_NCIt_Subsets.xml (xml)

Each file has column headers on the first row:

Spreadsheet Column Content Description

Source The initials of the requesting agency, in this case, the FDA.

NCIt Subset Code The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.

FDA Subset Name The name of the subset.

NCIt Concept Code The NCIt concept code attached to the concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.

FDA Source PT The preferred term attached to the concept.

FDA Source Synonym(s) FDA terms considered synonomous to the concept's preferred term.

FDA Source Definition A text definition of the term created by an FDA subject matter expert.

NCIt Definition A text definition of the term created by an NCI EVS subject matter expert.

Also included on the NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/CDRH/GUDID) are the following additional files:

About (This file)
FDA-CDRH-GUDID_NCIt_Changes.txt (A text file of changes between the most recent and the current version of CDRH-GUDID terminology. For each change record, the Changes.txt contains a complete row of tab delimited data with the same data elements as described above. An "A" will precede any new concept additions, a "C" will precede any modification to existing concepts, and a "D" will precede any concepts that have been deleted.) A term can be deleted from the CDRH GUDID subset, but not deleted from the NCIt thesaurus. There will be Design Note (a memo about a term) explaining any deprecations or retired concepts.
FDA-CDRH-GUDID_NCIt_Version.txt (A text file that contains the version of NCI Thesaurus that corresponds to the current spreadsheet data. The database is reconciled the last Monday of every month. The files will be posted during the following two weeks. The version appears as YR.MOweek. An example is 13.02d which corresponds to the year 2013, the month of February, and the "d" refers to the fourth Monday of the month.)

N.B.: If there are no changes to the data for a particular month, the files will not be reposted.

Contact Information and Updates: For questions about GUDID terminology, definitions or use in HL7 SPL submission, please contact the UDI Helpdesk.

Archived files are available at:

http://evs.nci.nih.gov/ftp1/FDA/CDRH/GUDID/

Archive/ Directory of dated release versions.

Help requests on these files should go to NCIThesaurus@mail.nih.gov

* If an attempt to view the Excel spreadsheet results in a page of nonsense characters, check the security settings in Excel to permit viewing. This is achievable by clicking the highlighted bar above the data, but below the menu bar in the spreadsheet.

Spreadsheet Column	Content Description
Source	The initials of the requesting agency, in this case, the FDA.
NCIt Subset Code	The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.
FDA Subset Name	The name of the subset.
NCIt Concept Code	The NCIt concept code attached to the concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.
FDA Source PT	The preferred term attached to the concept.
FDA Source Synonym(s)	FDA terms considered synonomous to the concept's preferred term.
FDA Source Definition	A text definition of the term created by an FDA subject matter expert.
NCIt Definition	A text definition of the term created by an NCI EVS subject matter expert.