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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 7-276
CLSI M38 3rd Edition
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
This standard describes the reference broth microdilution testing method for antifungal susceptibility testing
of filamentous fungi (moulds) that cause invasive and/or cutaneous fungal infections.1-10 This standard also
covers testing conditions, including inoculum preparation and inoculum , incubation time and
temperature, media formulation, and end-point determination criteria.1-9 QC reference ranges and limits and
specific epidemiological cutoff values (ECVs) are summarized in the current editions of CLSI documents
M6118 and M59,12 respectively.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.1640 Susceptibility Test Powders, Antimicrobial Class 2 JTT
§866.1640 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§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 Powders, Antimycobacterial Class 2 MJA
§866.1640 System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies Class 2 MYI
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1640 System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species Class 2 NIJ
§866.1640 System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Class 2 NQX
§866.1640 System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony Class 2 PMY
§866.1640 System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen Class 2 POC
§866.1640 Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates Class 2 PTJ
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
§866.1620 Discs, Elution Class 2 LTX
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
§866.1700 Culture Media, Antifungal, Susceptibility Test Class 2 MJE
Relevant FDA Guidance and/or Supportive Publications*
Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs Guidance for Industry, Issued December 2017.

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
 Jeffrey Brocious
 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.