Recognized standard
EP19 3rd Edition
FDA recognition 7-323 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-323 |
|---|---|
| Designation | EP19 3rd Edition |
| Title | A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 23, 2024 |
| Scope (excerpt) | EP19 is organized around the Test Life Phases Model, which is the concept that all test methods undergo establishment by a developer, followed by implementation by the end user, all sequentially. For the purposes of EP19, the term "test method" includes the processes, reagents, supplies… |
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: