Data Standards Catalog

28 April 2023 – the FDA published version 9.1 of the final updated guidance of the data standards catalog.

The FDA Data Standards Catalog (Catalog) 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 which 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. Sponsors and applicants should review the Catalog terms below, as well as any references associated with specific standards or terminologies. Starting in v9.0, dates throughout are listed as (MM/DD/YYYY).

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