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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 040 Date of Entry 08/14/2015 
FR Recognition Number 7-251
Standard
CLSI  EP05-A3 (Reaffirmed: September 2019)
Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
Scope/Abstract
This document provides guidance for evaluating the precision performance of quantitative measurement procedures. It is intended for manufacturers of quantitative measurement procedures and for laboratories that develop or modify such procedures.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
CFR 8629.10, 862, 864, 866
Relevant FDA Guidance and/or Supportive Publications*
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
 Marina V. Kondratovich
  FDA/CDRH/OPEQ/OIDRH/
  301-796-6036
  marina.kondratovich@fda.hhs.gov
 Samir Lababidi
  FDA/OC/ODT/ODAR/IS/
  240-402-8682
  samir.lababidi@fda.hhs.gov
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.
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