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  • 1.  Canadian investigational application question

    Posted 04-Dec-2019 11:46
    I have been involved with a number of Health Canada investigational applications.  I can't find specific guidance on this.  Suppose a manufacturer has an investigational device authorized for one particular indication.  We were recently approached by an investigator who has filed a drug clinical trial application (CTA) requesting to leverage our ITA (investigational testing authorization) device.  This device was approved for one indication.  But the new drug sponsor will be conducting a study with our device for another indication.  In this scenario, what are our obligations as a sponsor?  I heard through some sources about an authorization letter and some preclinical documents that we have to file, but I do not see any guidance on exactly what the manufacturer needs to do.  Also, if this is a new ITA for a whole different indication, why do they need to cross-reference a previous ITA? Can somebody shed some light on this?

    Thanks.

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    Karen Zhou
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  • 2.  RE: Canadian investigational application question

    Posted 04-Dec-2019 12:07
    Edited by Kevin Randall 04-Dec-2019 12:09
    If not done already, I recommend taking a look at: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance.html

    From a pure regulatory, safety, and efficacy standpoint, the pre-authorization requirements for investigational use of the device should generally be the same regardless of who is the Sponsor.  Specifically, if the indications encompassed by an existing ITA do not cover the indications targeted for any further investigational use, then an additional or expanded ITA would be needed.

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    Kevin Randall, ASQ CQA, RAC (Canada, U.S., Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden, CO
    United States
    www.complianceacuity.com
    © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: Canadian investigational application question

    Posted 04-Dec-2019 12:12
    Edited by Kevin Randall 04-Dec-2019 12:16
    And here's a link to the PDF version: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/investigational-testing-authorizations-guidance.pdf

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Canada, U.S., Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden, CO
    United States
    www.complianceacuity.com
    © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 4.  RE: Canadian investigational application question

    Posted 04-Dec-2019 12:16
    Note that an indication outside the scope of the existing ITA would likely demand a new ITA (not just a revision to an existing ITA).

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden, CO
    United States
    www.complianceacuity.com
    © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


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