Recognized standard
EP15-A3 (Reaffirmed: September 2019)
FDA recognition 7-253 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-253 |
|---|---|
| Designation | EP15-A3 (Reaffirmed: September 2019) |
| Title | User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | This document describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed within as few as five days. |
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: