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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 7-262
Standard
CLSI M45 3rd Edition
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
Scope/Abstract
CLSI documents M02, M07, and M100 describe standardized methods and interpretive criteria for antimicrobial susceptibility testing of common aerobic bacteria, including some fastidious organisms. However, a number of less frequently encountered or fastidious bacteria are not addressed in those CLSI documents despite their potential to cause serious infections. M45 addresses these latter organisms with the goal of providing recommendations for clinical microbiology laboratories on how and when to determine the susceptibility of these diverse organisms. This document also provides guidance for public health laboratory testing of bacteria potentially associated with bioterrorism.

This edition of M45 includes taxonomic updates and several new tables to address organisms more likely to be identified in laboratories using sequencing or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry for the identification of bacteria. The intent of this revision is to assist laboratories in determining an approach for testing that is relevant to their individual practice settings.

The methods provided may be used in clinical, public health, and research laboratories.

This guideline does not address commercial susceptibility testing devices.


This edition of M45 includes taxonomic updates and several new tables to address organisms more likely to be identified in laboratories using sequencing or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry for the identification of bacteria. The intent of this revision is to assist laboratories in determining an approach for testing that is relevant to their individual practice settings.

The methods provided may be used in clinical, public health, and research laboratories.

This guideline does not address commercial susceptibility testing devices.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Exceptions are noted on the FDA Antimicrobial Susceptibility Test Interpretive Criteria (STIC) (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm). In the absence of interpretive criteria and quality control parameters on this FDA webpage, consult the technical contacts below.
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.

This standard is recognized in part because:
Exceptions are noted on the FDA Antibacterial Susceptibility Test Interpretive Criteria webpage (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm). This webpage includes a table that lists antibacterial drugs and indicates which, if any, STIC are recognized or identified by FDA for that drug.
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 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§866.1640 Panels, Test, Susceptibility, Antimicrobial Class 2 LTT
§866.1640 Solution, Antimicrobial Class 2 LOP
§866.1640 Susceptibility Test Cards, Antimicrobial Class 2 LTW
§866.1640 Susceptibility Test Powders, Antimicrobial Class 2 JTT
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
§866.1700 Culture Media, Antimicrobial Susceptibility Test Class 2 LKA
§866.1700 Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Class 2 JSO
§866.1700 Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Class 2 JTZ
Relevant FDA Guidance and/or Supportive Publications*
FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial Susceptibility Test Interpretive Criteria https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm

Guidance for Industry and FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued August 2009.
FDA Technical Contacts
 Ribhi Shawar
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
 Natasha Griffin
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1
  301-796-0522
  Natasha.Griffin@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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