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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 7-152
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition.
This document contains a protocol that optimizes the experimental design for the evaluation of qualitative tests, to better measure performance and provide a structured data analysis.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of CLSI EP12-A2 [Rec# 7-152] will be superseded by recognition of CLSI EP12 3rd Edition [Rec# 7-315]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-152] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 7-152] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, Issued March 2007.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Gene Pennello
 Marina V. Kondratovich
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.