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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 050 Date of Entry 09/17/2018 
FR Recognition Number 7-276
Standard
CLSI  M38 3rd Edition
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
Scope/Abstract
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
§866.1620 Antimicrobial susceptibility test disc.
§866.1640 Antimicrobial susceptibility test powder.
§866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
§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
 Ribhi Shawar
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
 Jeffrey Brocious
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC2/
  240-402-3797
  jeffrey.brocious@fda.hhs.gov
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.
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