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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 053 Date of Entry 12/23/2019 
FR Recognition Number 7-294
CLSI M100, 29th ed. January 2019 (Replaces M100 28th ed). Performance Standards for Antimicrobial Susceptibility Testing
This standard includes updated tables for the CLSI antimicrobial susceptibility testing standards M02-A13, M07-A11, and M11-A8.
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.

Exceptions as noted on the Antimicrobial Susceptibility Test Interpretive Criteria cited below. In the absence of interpretive criteria and quality control parameters on the FDA website, consult the technical contacts.
Transition Period
FDA recognition of M100 28th ed [Rec# 7-281] will be superseded by recognition of CLSI M100, 29th ed. January 2019 [Rec# 7-294]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-281] until December 27, 2020. After this transition period, declarations of conformity to [Rec# 7-281] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.1640 Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems Class 2 LRG
§866.1640 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§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*
FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria: Antibacterial Susceptibility Test Interpretive Criteria https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm
FDA Technical Contacts
 Ribhi Shawar
 Patricia Conville
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.