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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 030 Date of Entry 01/15/2013 
FR Recognition Number 7-235
CLSI  EP25-A (Replaces EP25-P)
Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
This document provides guidance and regression-based procedures for establishing stability-related claims of in vitro diagnostic (IVD) reagents such as reagent kits, calibrators, control products, and sample diluents. This guideline was written primarily for manufacturers and regulatory agencies, but will also be of interest to clinical laboratories. It provides information on the design, implementation, data analysis, and documentation needs for studies to establish and verify shelf life and in-use life of IVD reagents. Additional topics address assessment of product transport conditions on stability and accelerated stability testing.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of CLSI EP25-A (Replaces EP25-P) [Rec# 7-235] will be superseded by recognition of CLSI EP25 2nd Edition [Rec# 7-318]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-235] until December 20, 2025. After this transition period, declarations of conformity to [Rec# 7-235] will not be accepted.
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 Contact
 Marina V. Kondratovich
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.