Recognized standard
EP06-EG 2nd Edition
FDA recognition 7-329 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-329 |
|---|---|
| Designation | EP06-EG 2nd Edition |
| Title | Developer Validation of Linearity, Establishment Guide |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 26, 2025 |
| Scope (excerpt) | CLSI EP06 provides essential guidance for validating and verifying the linearity of a measurement procedure's analytical measuring interval (AMI). This guideline outlines minimum procedures for both manufacturers and laboratory-developed test (LDT) developers to confirm linearity claims and ensure… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: