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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 031 Date of Recognition 08/06/2013 
FR Recognition Number 7-243
Standard
CLSI M51-A (Replaces M51-P)
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
Scope/Abstract
This document describes the guidelines for antifungal susceptibility testing by the disk diffusion method of nondermatophyte filamentous fungi (moulds) that cause invasive disease.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Section 8.1 Zone Diameter Epidemiological Cutoff Values
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.

Section 8.1 is in conflict with FDA approved drug labeling, see FDA- Antifungal Susceptibility Test Interpretive Criteria listed below.
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
Antifungal Susceptibility Test Interpretive Criteria website: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm
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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