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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 061 Date of Entry 12/18/2023 
FR Recognition Number 7-318
CLSI  EP25 2nd Edition
Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
This guideline provides information for establishing and verifying (confirming) shelf-life and in-use stability claims for quantitative in vitro diagnostic (IVD) medical laboratory reagents or products. The information also applies to qualitative IVD products, provided that an underlying continuous response or signal responsible for the qualitative result(s) is available to the investigator. This guideline also includes background information and typical content for creating a stability testing plan, determining the logistics for performing the studies, conducting recommended data analyses, and documenting stability claims for a product. Additional topics include assessment of product distribution conditions on stability claims (transport simulation), verification of stability claims, appropriate uses of accelerated testing, and considerations for testing with difficult samples.
The intended users of this guideline are primarily product manufacturers and regulatory agencies. Medical laboratorians may find this information useful for interpreting and confirming commercial product stability claims (eg, in-use life of QC materials), as well as for establishing stability attributes for laboratory-developed test methods. For this guideline, "products" is understood to encompass reagents, calibrators, controls, diluents, and similar materials that are used as IVD medical devices to conduct a measurement procedure for a measurand of medical interest.
This guideline does not cover instrument systems, laboratory equipment, software, or patient specimens. Stability testing of raw materials or components of reagent kits or consumables is not covered explicitly; however, the principles described in this guideline can be adapted by manufacturers for that purpose.
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 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.
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
 Marina V. Kondratovich
 Ying Mao
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.