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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 050 Date of Entry 09/17/2018 
FR Recognition Number 7-280
Standard
CLSI  M02 13th Edition
Performance Standards for Antimicrobial Disk Susceptibility Tests
Scope/Abstract
This standard describes the reference agar 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; and disk diffusion method limitations.
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.
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*
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
 Ribhi Shawar
  FDA/OC/CDRH/OPEQ/OIDRH/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
*These are provided as examples and others may be applicable.
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