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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 7-278
Standard
CLSI M27 4th Edition
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
Scope/Abstract
This standard covers antifungal agent selection and preparation, test procedure implementation and interpretation, and quality control requirements for susceptibility testing of yeasts that cause invasive fungal infections.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of CLSI M27-A3 [Rec# 7-204] will be superseded by recognition of CLSI M27 4th Edition [Rec# 7-278]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-204] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 7-204] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§866.1700 Culture Media, Antifungal, Susceptibility Test Class 2 MJE
§866.1640 Susceptibility Test Plate, Antifungal Class 2 NGZ
§866.1620 Discs, Elution Class 2 LTX
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
Relevant FDA Guidance and/or Supportive Publications
Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs Guidance for Industry, Issued December 2017.
FDA Technical Contacts
 Jeffrey Brocious
  FDA/OMPT/CDRH/OIR/DMD
  240-402-3797
  jeffrey.brocious@fda.hhs.gov
 Ribhi Shawar
  FDA/OMPT/CDRH/OIR/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
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