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.
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
EP12 Additional Details
If interested in ordering larger quantities of this document in print, please contact us here.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.