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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 059 Date of Entry 12/19/2022 
FR Recognition Number 7-313
Standard
CLSI  EP27 2nd Edition
Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
Scope/Abstract
This guideline provides recommendations on constructing and using error grids to evaluate the clinical acceptability of quantitative measurement procedures, based on the potential harm that may be caused by erroneous measurements with clinical consequences. This guideline is intended for use by laboratories and manufacturers (collectively referred to as "developers") and users of quantitative measurement 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FDA recognition of CLSI EP27-A [Rec# 7-291] will be superseded by recognition of CLSI EP27 [Rec# 7-313]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-291] until December 17, 2024. After this transition period, declarations of conformity to [Rec# 7-291] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures.

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
 Paula Caposino
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/CRDB/
  301-796-6160
  paula.caposino@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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