Food Authenticity Program Meeting Book (March 13, 2020)

PURPOSE

www.fda.gov • Establishes criteria by which all analytical methods for specific nucleotide sequence- based analyses in foods, feed and cosmetics to be used in FDA laboratories shall be evaluated and validated. • The requirements described here will only apply to newly -developed methods and those for which significant modifications have been made to an existing method. VALIDATION LEVELS Level One •Single laboratory validation level with the fewest validation requirements, and is suggested for emergency or limited use. Level Two •This is a single laboratory validation level. The originating laboratory has conducted a Level One validation, and compared the new method with an existing reference method if appropriate

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www.fda.gov