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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 7-324
Standard
CLSI  M07 12th Edition
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
Scope/Abstract
This standard describes standard broth (macrodilution and microdilution) and agar dilution methods for determining in vitro susceptibility to antimicrobial agents for bacteria that grow aerobically and includes:
- Broth and agar dilution test preparation
- Testing conditions, including inoculum preparation and standardization, incubation time, and incubation temperature
- Results interpretation
- QC procedures
- Dilution test method limitations
To assist the medical laboratory, recommendations are provided for selecting antimicrobial agents for routine testing and reporting...
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FDA recognition of CLSI M07 11th Edition [Rec# 7-279] will be superseded by recognition of CLSI M07 12th Edition [Rec# 7-324]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-279] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 7-279] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.1640 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§866.1640 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class 2 LRG
§866.1640 Panels, Test, Susceptibility, Antimicrobial Class 2 LTT
§866.1640 Susceptibility Test Cards, Antimicrobial Class 2 LTW
§866.1645 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class 2 LON
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, issued March 2007.

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
 Hannah Livesay
  CDRH/OPEQ/OHTVII/DMD/BAC1/
  --
  hannah.livesay@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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