| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
060
|
Date of Entry 05/29/2023
|
|
FR Recognition Number
|
7-317
|
| Standard | |
CLSI M100 33rd, Edition
Performance Standards for Antimicrobial Susceptibility Testing |
|
Scope/Abstract| The data in the tables are valid only if the methodologies in CLSI documents M02, M07, and M11 are followed. These standards contain information about disk diffusion (M02) and dilution (M07 and M11) test procedures for aerobic and anaerobic bacteria. Clinicians depend heavily on information from the microbiology laboratory for treating their seriously ill patients. The clinical importance of antimicrobial susceptibility test results demands that these tests be performed under optimal conditions and that laboratories have the capability to provide results for the newest antimicrobial agents. The tables presented in M100 represent the most current information for drug selection, interpretation, and quality control using the procedures standardized in M02, M07 and M11. Users should replace previously published tables with these new tables. Changes in the tables since the previous edition appear in boldface type. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Exceptions are noted on the FDA Antimicrobial Susceptibility Test Interpretive Criteria (STIC) webpage (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm). In the absence of interpretive criteria and quality control parameters on this FDA webpage, consult the technical contacts below. |
|
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.
This standard is recognized in part because:
Exceptions are noted on the FDA Antibacterial Susceptibility Test Interpretive Criteria webpage (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm575163.htm). This webpage includes a table that lists antibacterial drugs and indicates which, if any, STIC are recognized or identified by FDA for that drug. |
|
Transition Period
| FDA recognition of CLSI M100, 33rd Edition [Rec# 7-317] will be superseded by recognition of CLSI M100 34th Edition [Rec# 7-327]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-317] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 7-317] 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
|
| §866.1640 |
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*
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 Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
