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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 028 Date of Recognition 03/16/2012 
FR Recognition Number 7-204
Standard
CLSI M27-A3
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
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FDA recognition of CLSI M27-A3 [Rec# 7-204] will be superseded by recognition of CLSI M27 4th Edition [Rec# 7-278].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
There is no relevant guidance developed at this time.
FDA Technical Contact
 Jeffrey Brocious
  FDA/OMPT/CDRH/OIR/DMD
  240-402-3797
  jeffrey.brocious@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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