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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 056 Date of Entry 06/07/2021 
FR Recognition Number 7-292
Standard
CLSI  M62 1st Edition
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
Scope/Abstract
Clinical and Laboratory Standards Institute document M62-Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes includes the minimal inhibitory concentrations and quality control ranges developed following the standards described in CLSI document M24. The data in the tables are valid only when the methodology in CLSI document M24 is followed.
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 Susceptibility Test Discs, Antimicrobial Class 2 JTN
§866.1640 Susceptibility Test Powders, Antimycobacterial Class 2 MJA
§866.1700 Culture Media, Antimycobacteria, Susceptibility Test Class 2 MJD
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.


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
 Robyn AtkinsonDunn
  CDRH/OPEQ/OHTVII/DMD/BAC1
  --
  robyn.atkinsondunn@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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