Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
063
|
Date of Entry 12/23/2024
|
FR Recognition Number
|
7-326
|
Standard | |
CLSI M24S 2nd Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes |
|
Scope/AbstractThe tables in this document are intended for use with CLSI document M24 that provides protocols and related quality control parameters for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes. This document(M24S) includes updated breakpoint and quality control tables for the Clinical and Laboratory Standards Institute susceptibility testing standard M24. |
|
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized: |
Table 1. Broth Microdilution Breakpoints and Interpretive Categories for MTBC Tested in Middlebrook 7H9 Broth Supplemented With OADC Using MIC Panels
Table 2. Susceptibility Testing of MTBC to Second-Line Drugs Using the Fluorescence-based Commercial Shorter-Incubation Liquid Media System
Table 3. Antimicrobial Agents and Breakpoints for Testing MAC
Table 4. Antimicrobial Agents and Breakpoints for Testing Mycobacterium kansasii
Table 5. Antimicrobial Agents and Breakpoints for Testing Slowly Growing Nontuberculous Mycobacteria Other Than MAC and Mycobacterium kansasii
Table 6. Antimicrobial Agents and Breakpoints for Testing Rapidly Growing Mycobacteria
Table 7. Antimicrobial Agents and Breakpoints for Testing Nocardia spp. and Other Aerobic Actinomycetes
Table 8. Expected Antimicrobial Susceptibility Patterns of the Most Commonly Isolated Nocardia spp
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 FDA 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: Tables 1-8 are in conflict with an existing regulation, 21st Century Cures Act, Section 3044.
Exceptions are noted on the FDA Antimicrobial Susceptibility Test Interpretive Criteria (STIC) (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. |
|
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. |
|
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
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 Contacts
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |