Recognized standard
EP39, 1st Edition
FDA recognition 7-311 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-311 |
|---|---|
| Designation | EP39, 1st Edition |
| Title | A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 20, 2021 |
| Scope (excerpt) | This guideline establishes a definition of "surrogate sample" and an approach for selecting, preparing, and using these samples. It discusses surrogate sample: - Composition - Technical preparation - Selection criteria - Documentation and planning - Use in specific performance study types The… |
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: