Performance Evaluation for IVDs
IVD (in vitro diagnostic) devices follow a performance evaluation pathway rather than the traditional clinical evaluation pathway used for invasive and implantable devices. Performance evaluation focuses on analytical and clinical validity rather than safety and clinical benefit.
Componentsβ
- Analytical performance: accuracy, precision, linearity, interference, cross-reactivity, reference intervals
- Clinical performance: sensitivity, specificity, PPV, NPV vs reference method
- Scientific validity: evidence that the analyte has the claimed clinical relevance
By gradeβ
| Grade | Requirements |
|---|---|
| A/B | Analytical performance data; literature review |
| C/D | Formal clinical performance studies; reference laboratory confirmation |
Companion diagnosticsβ
Require coordination with the drug's approval process β MFDS pharmaceutical division consulted. See Companion diagnostics.