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Investigational Testing Authorization (ITA)

What is an ITA?​

An Investigational Testing Authorization (ITA) is the authorisation required from Health Canada to use an unlicensed medical device in a clinical investigation in Canada. The ITA is the Canadian equivalent of:

  • Investigational Device Exemption (IDE) — United States (FDA)
  • Clinical Investigation Authorisation — European Union (MDR Art. 62)
  • CTN (Clinical Trial Notification) / CTX (Clinical Trial Exemption) — Australia (TGA)

When is an ITA required?​

An ITA is required when:

  • A device is being investigated for safety and/or effectiveness
  • The device does not yet hold a Device Licence in Canada (or is being studied for an indication beyond its current licence)
  • The investigation involves administering the device to human subjects

An ITA is not required if the device holds a current Device Licence and is being used within its licensed intended use (even in a clinical study context).

Who submits an ITA?​

The sponsor of the clinical investigation submits the ITA. The sponsor is typically the manufacturer or the clinical investigator's institution, depending on the trial structure.

ITA application contents​

An ITA application must include:

Device information​

  • Device description and intended use for the investigation
  • Manufacturing information
  • Preclinical safety data supporting the use in humans
  • Risk analysis (ISO 14971)
  • Proposed labelling for investigational use

Clinical investigation plan​

  • Study objectives and design (protocol)
  • Patient population and eligibility criteria
  • Investigator qualifications
  • Clinical sites
  • Monitoring plan
  • Informed consent process

Ethics board approval​

  • Evidence of Research Ethics Board (REB) approval (or confirmation that approval is pending/planned)

ITA review process​

  1. Submit ITA application via the Health Canada e-Submission portal (HRES)
  2. Health Canada screens the application for completeness (Screening Deficiency Notice if incomplete)
  3. Health Canada reviews the safety and ethics of the proposed investigation
  4. ITA issued (or refused with reasons)
  5. Investigation may begin after ITA issuance and REB approval

ITA conditions​

ITAs are issued with conditions that must be followed during the investigation:

  • Device may only be used as specified in the approved protocol
  • Serious Adverse Device Effects (SADEs) must be reported to Health Canada promptly
  • Amendments to the study protocol require Health Canada approval
  • Study must follow ICH E6(R2) GCP guidelines

Post-ITA​

Data generated under an ITA may be used to support a subsequent Device Licence application. The clinical data package should be referenced in the Device Licence application.

Legislative source: Medical Devices Regulations, SOR/98-282, ss 66–89 (Investigational Testing)