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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 064 Date of Entry 05/26/2025 
FR Recognition Number 7-330
Standard
CLSI  M38M51S 3rd Edition
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
Scope/Abstract
This document provides minimal inhibitory concentration (MIC) breakpoints and quality control (QC) tables for use with CLSI antifungal susceptibility testing standards M38 and M51. It ensures laboratories have the most up-to-date reference data for accurate and standardized susceptibility testing of filamentous fungi and other clinically relevant fungi.
Clinical and Laboratory Standards Institute document M38M51S-Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi includes minimal inhibitory concentration and quality control tables developed following the guidance in CLSI documents M38(1) and M51.(2) The data in the tables are valid only when the methodologies in CLSI documents M38(1) and M51(2) are followed. Users should replace previously published tables with these new tables. Changes in the tables since the previous edition was published appear in boldface type.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
FDA recognizes the breakpoints in this standard unless exceptions and/or additions are identified on the FDA Antimicrobial Susceptibility Test Interpretive Criteria (STIC) webpage (https://www.fda.gov/drugs/development-resources/antifungal-susceptibility-test-interpretive-criteria). For additional information, 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:

FDA recognizes the breakpoints in this standard unless exceptions and/or additions are identified on the FDA Antimicrobial Susceptibility Test Interpretive Criteria (STIC) webpage (https://www.fda.gov/drugs/development-resources/antifungal-susceptibility-test-interpretive-criteria). For additional information, consult the technical contacts below.
Relevant FDA Guidance and/or Supportive Publications*
FDA-Recognized Antifungal Susceptibility Test Interpretive Criteria: Antifungal Susceptibility Test Interpretive Criteria https://www.fda.gov/drugs/development-resources/antifungal-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
 Ribhi Shawar
  FDA/OC/CDRH/OPEQ/OHTVII/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
 Courtney Chandler
  FDA/OC/CDRH/OPEQ/OHTVII/DMD/BAC1/
  --
  courtney.chandler@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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