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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 7-303
Standard
CLSI M60 2nd Edition
Performance Standards for Antifungal Susceptibility Testing of Yeast
Scope/Abstract
This document provides updated minimal inhibitory concentration, zone diameter, and quality control tables for the Clinical and Laboratory Standards Institute antifungal susceptibility testing documents M27 and M44.
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.

Interpretive criteria and quality control parameters when different from that in FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antifungal Susceptibility Test Interpretive Criteria. See relevant guidance below for information on interpretive criteria.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.1620 Discs, Elution Class 2 LTX
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1700 Culture Media, Antifungal, Susceptibility Test Class 2 MJE
Relevant FDA Guidance and/or Supportive Publications*
FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antifungal Susceptibility Test Interpretive Criteria https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575166.htm
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
 Patricia Conville
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1/
  301-796-6942
  patricia.conville@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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