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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 7-239
Standard
CLSI  EP32-R (Formerly X05-R)
Metrological Traceability and Its Implementation; A Report
Scope/Abstract
This document provides guidance to manufacturers for establishing and reporting metrological traceability.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of CLSI EP32-R (Formerly X05-R) [Rec# 7-239] will be superseded by recognition of CLSI EP32 Second Edition [Rec# 7-346]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-239] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 7-239] will not be accepted.
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 Contact
 Marina V. Kondratovich
  FDA/CDRH/OPEQ/OIDRH/
  301-796-6036
  marina.kondratovich@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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