The submission of data using standards or terminologies not listed in the Catalog should be discussed with the Agency in advance. Where the Catalog expresses support for more than one standard or terminology for a specific use, the sponsor or applicant may select one to use or can discuss, as appropriate, with their review division. Version 7.0 of the FDA Data Standards Catalog dated 03-15-2021, specifies that MED-RT was a required terminology by the White House Consolidated Health Informatics Initiative in various Federal Register Notices beginning as early as May 6, 2004, for NDAs, ANDAs, and certain BLAs beginning on December 17, 2016, and for certain IND's beginning on December 17, 2017. https://www.fda.gov/media/85137/download