Recognized standard
M23 6th Edition
FDA recognition 7-319 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-319 |
|---|---|
| Designation | M23 6th Edition |
| Title | Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This 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… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: