Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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7-288
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Standard | |
CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes |
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Scope/AbstractThis standard provides protocols and related quality control parameters and interpretive criteria for the susceptibility testing of mycobacteria, Nocardiae spp. and other aerobic actinomycetes. |
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Extent of Recognition
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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.
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. |
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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*
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. |