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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 055 Date of Entry 12/21/2020 
FR Recognition Number 7-304
CLSI  M23 5th Edition
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
This guideline provides direction for determining breakpoints and QC parameters for antimicrobial agents that have a direct action on microorganisms. The intended audience includes sponsors (eg, antimicrobial agent manufacturers) planning to submit data to establish or revise QC ranges and susceptibility testing breakpoints and interpretive categories for inclusion in CLSI susceptibility testing documents. The methods described do not apply to:
. Slow-growing mycobacteria, for which specific guidance is available (see CLSI document M2412)
. Antimicrobial agents formulated for direct administration to skin or mucous membranes or for inhalation
. Antimicrobial agents that are intended to exert activity within the gut lumen

Guidance presented in M23 applies only to CLSI procedures and documents.
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FDA recognition of CLSI M23 5th Edition [Rec# 7-304] will be superseded by recognition of CLSI M23 6th Edition [Rec# 7-319]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-304] until December 20, 2025. After this transition period, declarations of conformity to [Rec# 7-304] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
§866.1620 Discs, Elution Class 2 LTX
§866.1640 Susceptibility Test Powders, Antimicrobial Class 2 JTT
§866.1640 Reagent/Device, Inoculum Calibration Class 2 LIE
§866.1640 Solution, Antimicrobial Class 2 LOP
§866.1640 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class 2 LRG
§866.1640 Panels, Test, Susceptibility, Antimicrobial Class 2 LTT
§866.1640 Susceptibility Test Cards, Antimicrobial Class 2 LTW
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
§874.4420 Press, Vein Class 1 JYW
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
 Ribhi Shawar
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.