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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 065 Date of Entry 12/22/2025 
FR Recognition Number 7-346
Standard
CLSI  EP32 2nd Edition
Implementation of Metrological Traceability in Laboratory Medicine
Scope/Abstract
CLSI EP32 provides information for implementing metrological traceability according to ISO 17511. It describes the necessary components and their use for in vitro diagnostic medical device (IVD MD) manufacturers to correctly establish, implement, and maintain metrological traceability. CLSI EP32 explains different calibration hierarchies for end-user medical laboratory measuring systems that are metrologically traceable to the highest available measurement procedures (MPs) and calibration materials.
CLSI EP32 describes related procedures (e.g., commutability assessment, estimation of measurement uncertainty [MU], and analytical performance specifications [APS]) used in implementing metrological traceability. However, CLSI EP32 refers to other publications for detailed design and execution of these procedures.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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FDA recognition of CLSI EP32-R (Formerly X05-R) [Rec# 7-239] will be superseded by recognition of CLSI EP32 Second Edition [Rec# 7-346].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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR 58 Good Laboratory Practice for Non-Clinical Studies
21 CFR 820 Quality Systems Regulations
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
 Paul Liu
  FDA/OC/CDRH/OPEQ/OHTVII/DMD/VIR2/
  240-402-3837
  paul.liu@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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