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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 052 Date of Entry 07/15/2019 
FR Recognition Number 7-291
How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
This guideline describes what an error grid is, why it is useful, and how to construct and interpret the information. Guidance is provided for manufacturers and for the clinical laboratory.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
5.9 Goals or Acceptance Criteria
5.10.2 Sample
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.

Sections 5.9 and 5.10.2 are in conflict with another recognized standard. See CLSI EP21 2nd Edition, ID Section, listed below.
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FDA recognition of CLSI EP27-A [Rec# 7-291] will be superseded by recognition of CLSI EP27 [Rec# 7-313].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
 Gene Pennello
 Leslie Landree
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.