| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
061
|
Date of Entry 12/18/2023
|
|
FR Recognition Number
|
7-319
|
| Standard | |
CLSI M23 6th Edition
Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters |
|
Scope/AbstractThis guideline provides direction for determining breakpoints and QC parameters for antimicrobial agents that have a direct action on microorganisms. The intended audience includes sponsors (e.g., antimicrobial agent manufacturers) planning to submit data to establish or revise QC ranges and susceptibility testing breakpoints and interpretive categories for inclusion in CLSI susceptibility testing documents. The methods described do not apply to:
- Slow-growing mycobacteria, for which specific guidance is available (see CLSI document M24)
- Antimicrobial agents formulated for direct administration to skin or mucous membranes or for inhalation
- Antimicrobial agents that are intended to exert activity within the gut lumen
Guidance presented in M23 applies only to CLSI procedures and documents. |
|
| Extent of Recognition
|
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| FDA recognition of CLSI M23 5th Edition [Rec# 7-304] will be superseded by recognition of CLSI M23 6th Edition [Rec# 7-319]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-304] until December 20, 2025. After this transition period, declarations of conformity to [Rec# 7-304] 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
|
| §866.1640 |
Susceptibility Test Powders, Antimicrobial
|
Class 2
|
JTT
|
| §866.1640 |
Manual Antimicrobial Susceptibility Test Systems
|
Class 2
|
JWY
|
| §866.1640 |
Reagent/Device, Inoculum Calibration
|
Class 2
|
LIE
|
| §866.1640 |
Solution, Antimicrobial
|
Class 2
|
LOP
|
| §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
|
| §866.1640 |
Susceptibility Test Plate, Antifungal
|
Class 2
|
NGZ
|
| §866.1645 |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
|
Class 2
|
LON
|
|
Relevant FDA Guidance and/or Supportive Publications*
| 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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
