Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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7-292
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Standard | |
CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes |
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Scope/AbstractClinical 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. |
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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. |
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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. |
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Transition Period
FDA recognition of CLSI M62 1st Edition [Rec# 7-292] will be superseded by recognition of CLSI M24S 2nd Edition [Rec# 7-326]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-292] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 7-292] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§866.1620 |
Susceptibility Test Discs, Antimicrobial
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Class 2
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JTN
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§866.1640 |
Susceptibility Test Powders, Antimycobacterial
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Class 2
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MJA
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§866.1700 |
Culture Media, Antimycobacteria, Susceptibility Test
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Class 2
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MJD
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |