FDA-Recognized Consensus Standards

The United States Food and Drug Administration (FDA) identifies voluntary consensus standards for which they will accept a declaration of conformity validating that the manufacturer has met relevant requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA may recognize all, part, or none of a standard established by a national or international SDO. This crosswalk provides a quick reference to those CLSI clinical and laboratory standards recognized by the FDA.

If there are any discrepancies between the CLSI FDA-Recognized Consensus Standards and the FDA-Recognized Consensus Standards Database, the FDA database should be regarded as the definitive source.

(Note: CLSI standards and guidelines can be located in the FDA database by searching on “CLSI” and/or “NCCLS.”)

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