FDA Quality Metrics Terminology Subset Files

The FDA Quality Metrics-NCIt terminology files provided here support the cooperative efforts of the FDA and the National Cancer Institute's Thesaurus (NCIt) to develop terminology that facilitates the processing and review data submitted related to the measurements to help the FDA evaluate the quality of the facilities and the processes that manufacturers use to make FDA-regulated drugs and biologics. For more information, see the FDA Voice web page.

Quality Metrics terminology files are available for download from this NCI EVS ftp site (https://evs.nci.nih.gov/ftp1/FDA/QualityMetrics/) in two formats:

FDA-Quality_Metrics_Terminology.xls
FDA-Quality_Metrics_Terminology.txt (Tab-delimited text)

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.
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.
Subset Name The name of the subset.
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.
Source PT The FDA preferred term attached to the concept.
Source Synonym(s) FDA terms considered synonomous to the concept's preferred term.


The Quality Metrics is bundled into subsets, identified by code and name in the second and third columns of each row. These are the names and definitions of the subsets.

Subset Name Subset Description
FDA Establishment Activity Terminology Terminology used in the framework of identifying types of establishment activities.
FDA Application Type Terminology Terminology used in the framework of identifying types of pharmaceutical application types.

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

About (This file)
Changes.txt (A text file of changes between the most recent and the current version of CDRH 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.)
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 15.08d which corresponds to the year 2015, the month of August, 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.

Archived files are available at:

  • Archive Directory of dated release versions.

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