Translations:Medical classification/28/en

The United States Food and Drug Administration publishes a Data Standards Catalog that lists the data standards and terminologies that FDA supports for use in regulatory submissions to better enable the evaluation of safety, effectiveness, and quality of FDA-regulated products. In addition, the FDA has the statutory and regulatory authority to require certain standards and terminologies and these are identified in the Catalog with the date the requirement begins and, as needed, the date the requirement ends, and information sources. 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