Recognized standard
EP35 2nd Edition
FDA recognition 7-349 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-349 |
|---|---|
| Designation | EP35 2nd Edition |
| Title | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | CLSI EP35 provides recommendations on establishing clinical equivalence or suitability for multiple specimen types for a single measurement procedure. This guideline provides a protocol for assessing equivalence or suitability for use of a different specimen type compared with the established… |
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: