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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 059 Date of Entry 12/19/2022 
FR Recognition Number 7-314
CLSI  M27M44S, 3rd Edition
Performance Standards for Antifungal Susceptibility Testing of Yeasts
Clinical and Laboratory Standards Institute document M27M44S - Performance Standards for Antifungal Susceptibility Testing of Yeasts includes minimal inhibitory concentration, zone diameter, and quality control tables developed following the guidance in CLSI documents M27 and M44 The data in the tables are valid only when the methodologies in CLSI documents M27 and M44 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:
Exceptions are noted on the FDA Antimicrobial Susceptibility Test Interpretive Criteria (STIC) webpage (https://www.fda.gov/drugs/development-resources/fda-recognized-antimicrobial-susceptibility-test-interpretive-criteria). In the absence of interpretive criteria and quality control parameters on this FDA webpage, 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:
Exceptions are noted on the FDA Antifungal Susceptibility Test Interpretive Criteria webpage (https://www.fda.gov/drugs/development-resources/antifungal-susceptibility-test-interpretive-criteria). This webpage includes a table that lists antifungal drugs and indicates which, if any, STIC are recognized or identified by FDA for that drug.
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 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§866.1640 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class 2 LRG
§866.1640 Panels, Test, Susceptibility, Antimicrobial Class 2 LTT
§866.1640 Susceptibility Test Cards, Antimicrobial Class 2 LTW
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
§866.1700 Culture Media, Antifungal, Susceptibility Test Class 2 MJE
Relevant FDA Guidance and/or Supportive Publications*
FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial Susceptibility Test Interpretive Criteria https://www.fda.gov/drugs/development-resources/fda-recognized-antimicrobial-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 Contact
 Natasha Griffin
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.