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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 063 Date of Entry 12/23/2024 
FR Recognition Number 7-325
Standard
CLSI  M02 14th Edition
Performance Standards for Antimicrobial Disk Susceptibility Tests
Scope/Abstract
This standard describes the reference disk diffusion method used to determine the in vitro antimicrobial susceptibility of bacteria that grow aerobically and includes:
- Agar plate preparation
- Testing conditions, including inoculum preparation and standardization, incubation time, and incubation temperature
- Results interpretation
- QC procedures
- Disk diffusion method limitations
To assist the medical laboratory, recommendations are provided for selecting antimicrobial agents for routine testing and reporting...
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Appendix E. Test for Performing Disk Diffusion Directly from Positive Blood Culture Broth
Rationale for Recognition
Appendix E. is in conflict with an existing regulation, 21 CFR 866.1620, which states bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface rather than positive blood culture broth directly on an agar surface.
Transition Period
FDA recognition of CLSI M02 13th Edition [Rec# 7-280] will be superseded by recognition of CLSI M02 14th Edition [Rec# 7-325]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-280] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 7-280] will not be accepted.
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
§866.1620 Discs, Elution Class 2 LTX
Relevant FDA Guidance and/or Supportive Publications*
FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial Susceptibility Test Interpretive Criteria https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm

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/OIDRH/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
 Rebecca Weingarten
  FDA/CDRH/OHT7/DMD/BAC1/
  --
  Rebecca.Weingarten @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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