Recognized standard
EP21 3rd Edition
FDA recognition 7-347 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-347 |
|---|---|
| Designation | EP21 3rd Edition |
| Title | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | CLSI EP21 provides guidance for understanding, estimating, and evaluating the acceptability of total analytical error (TAE) for quantitative medical laboratory measurement procedures. This guidance is suitable for both commercially manufactured products as well as laboratory-developed tests (LDTs)… |
At a glance
- None 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: