Recognized standard
EP32 2nd Edition
FDA recognition 7-346 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-346 |
|---|---|
| Designation | EP32 2nd Edition |
| Title | Implementation of Metrological Traceability in Laboratory Medicine |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | CLSI EP32 provides information for implementing metrological traceability according to ISO 17511. It describes the necessary components and their use for in vitro diagnostic medical device (IVD MD) manufacturers to correctly establish, implement, and maintain metrological traceability. CLSI EP32… |
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: