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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 7-347
Standard
CLSI  EP21 3rd Edition
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
Scope/Abstract
CLSI EP21 provides guidance for understanding, estimating, and evaluating the acceptability of total analytical error (TAE) for quantitative medical laboratory measurement procedures. This guidance is suitable for both commercially manufactured products as well as laboratory-developed tests (LDTs). It is also useful for medical laboratories to assess the performance of measurement procedures intended to be put into use. Allowable total error (ATE) limits should be determined before CLSI EP21 is used to estimate and assess TAE. Users should consult CLSI EP46 for guidance for setting limits for ATE, with consideration to how test results are used to inform patient care.
The intended users of CLSI EP21 are developers of measurement procedures (both commercial manufacturers and laboratories with LDTs), regulatory authorities, and medical laboratory personnel.
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FDA recognition of CLSI EP21 2nd Edition (Replaces EP21-A) [Rec# 7-268] will be superseded by recognition of CLSI EP21 3rd Edition (Replaces EP21-A) [Rec# 7-347]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-268] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 7-268] 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
 Leslie Landree
  FDA/OC/CDRH/OPEQ/OHTVII/DCTD/DB/
  301-796-6147
  leslie.landree@fda.hhs.gov
 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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