Crosswalk of Documents Referenced Within FDA Accreditation Checklists

The US 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.

More information about the appropriate use of Voluntary Consensus Standards for approval by FDA can be found here. If there are any discrepancies between the 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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