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Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition

This guideline includes descriptions of the types of qualitative, binary output examinations and procedures for evaluating their performance.

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Chairholder: Jeffrey R. Budd, PhD

Date of Publication: March 7, 2023

Order Code PDF: EP12Ed3E
ISBN Number: 978-1-68440-177-2

Order Code Print: EP12Ed3
ISBN Number: 978-1-68440-176-5

Edition: Third

Pages: 140

EP12 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.