Recognized standard
EP35, 1st Edition
FDA recognition 7-298 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-298 |
|---|---|
| Designation | EP35, 1st 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 | Jul 6, 2020 |
| Scope (excerpt) | This guideline provides a protocol for assessing equivalence or suitability for use of a different specimen type compared with the established primary specimen type for a medical laboratory measurement procedure or qualitative examination. This guideline provides a general framework for studies that… |
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: