• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 7-296
CLSI  EP09c 3rd Edition
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
This guideline provides recommendations for designing an experiment and selecting methods to quantify systematic measurement error (bias or difference) between measurement procedures based on comparing patient samples. It provides both difference plot and regression procedures to determine the relationship between two measurement procedures either across their measuring intervals or at selected concentrations. Intended users of this guideline are manufacturers of in vitro diagnostic (IVD) reagents - which includes those who create laboratory-developed tests-as well as regulatory authorities and medical laboratory personnel.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Chapter 2 Introduction to Measurement Procedure Comparison and Bias Estimation.
Subchapter 2.2 Introduction.
Subchapter Establishing the Relationship between Measurement Procedures by the Manufacturer.
Subchapter Validation by the Manufacturer.
Chapter 3 Preparing for the Measurement Procedure Comparison Study.
Chapter 5 Visual Data Analysis.
Chapter 6 Quantitative Analysis.
Subchapter 6.1 Estimating Bias from Difference Plots.
Subchapter 6.2.4 Aberrant Results.
Subchapter 6.2.5 Nonlinear Distribution.
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.

Standard is recognized on a scientific basis: Device performance.

This standard is recognized in part because:

Chapter 2 Subchapters 2.2,, and, Chapters 3, 5 and 6 Subchapters 6.1, 6.2.4 and 6.2.5 do not satisfy the requirement for analytical performance characteristics under 21 CFR 809.10(b)(12) Specific Performance Characteristics (accuracy) and because it describes requirements for verification in clinical laboratories and not for submitters of premarket submissions.
Relevant FDA Guidance and/or Supportive Publications*
21 CFR 809.10(b)(12) Specific Performance Characteristics.

CLSI EP19, 2nd Edition, A Framework for Using CLSI Documents to Evaluate Clinical 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
 Yung Chan
 Marina V. Kondratovich
 Gene Pennello
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.