Investigational Testing Authorization (ITA)
The ITA page in this section is a cross-reference. For the full ITA guide, see:
→ Investigational Testing Authorization (ITA) — in the Pre-Market → Clinical Evidence section.
Quick summary
| Element | Details |
|---|---|
| Purpose | Authorise use of an unlicensed device in a clinical investigation |
| Who applies | Sponsor of the clinical investigation |
| Submitted to | Health Canada via HRES portal |
| Key document | Clinical investigation plan (protocol) |
| REB required | Yes — Research Ethics Board approval must be in place or pending |
| Reporting during trial | Serious Adverse Device Effects (SADEs) must be reported promptly |
| Post-ITA | Data may be used to support subsequent Device Licence application |
Legislative source: Medical Devices Regulations, SOR/98-282, ss 72–89 (Investigational Testing)