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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 052 Date of Entry 07/15/2019 
FR Recognition Number 7-288
Standard
CLSI  M24 3rd Edition
Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
Scope/Abstract
This standard provides protocols and related quality control parameters and interpretive criteria for the susceptibility testing of mycobacteria, Nocardiae spp. and other aerobic actinomycetes.
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 are not recognized when different from that in FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial 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 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*
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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