Recognized standard
EP19 2nd Edition (Replaces EP19-R)
FDA recognition 7-266 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-266 |
|---|---|
| Designation | EP19 2nd Edition (Replaces EP19-R) |
| 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 | Sep 21, 2016 |
| Scope (excerpt) | CLSI EP19-Ed2 uses the "measurement procedure lifecycle" framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory-developed tests. |
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: