July 13, 2010 This directory contains data files with controlled terminology used by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and maintained as distinct terminology subsets in NCI Thesaurus. Three sets of CDRH terminology are covered by these files: 1. Medical Device Component Or Accessory Terminology FDA CDRH 2. Medical Device Problem Codes FDA CDRH 3. Patient Problem Codes FDA CDRH Important Changes to Data Formats Starting with 2009-09-27, FDA changed data formats several times to provide additional information on FDA term parents and other data beyond the initial format used for other FDA terminology sets. Earlier files are in an "Original Format" subdirectory of the Archive directory. 2009-12-28 (NCIt 09.12d) starts a simplified format, dropping the previous columns M-O and making remaining column names more consistent. Also dropped are the first two rows that previously gave version information, now found in the tab name and dated version naming. Starting 2010-07-13, CDRH subsets are available in XML format. Current element and attribute mappings to Excel columns are as follow: A=source B=subset_code C=subset_name D=nci_code E=fda_code F=fda_pt G=fda_synonym H=fda_definition I=nci_definition J=parent_ncicode K=parent_fdacode L=parent_fdapt Starting 2010-08-12, a hierarchical view of the subsets is available. Displayed by CDRH preferred term, and based off CDRH parentage in tabbed text. Contents - Files: FDA-CDRH_NCIt_Hierarchy.txt (CDRH subsets' hierarchy: tabbed text) FDA-CDRH_NCIt_Subsets.txt (CDRH subsets in NCI Thesaurus: tabbed text) FDA-CDRH_NCIt_Subsets.xls (CDRH subsets in NCI Thesaurus: Excel) FDA-CDRH_NCIt_Subsets.xml (CDRH sbusets in NCI Thesaurus: XML) Pre-ProductionChanges.txt (Real-time changes for future version of NCIt) ReadMe.txt (this file) Contents - Directories: Archive (dated versions of all files, including current) Background: Additional documentation, data files, and related information are available on this Web page: http://www.cancer.gov/cancertopics/terminologyresources/FDA