Hi,
I have prepared dozens of ITA applications over the years and many "amendments" to these ITA. It is not necessary to do the changes in track changes as long as you are clear about what has changed. I'm assuming that your device is either Class III or IV based on the fact that you mention that you included V&V testing. My suggestion would be to include a very clear summary of what the changes are in the design (in the form of a comparison table is ideal), why they were done and whether further testing was required to validate the change. If testing was done to validate the change, point to where the summary of the testing is included in the submission and also include a copy of the protocol and study report as supporting documentation.
Make it very clear as to why the changes in design were made, was it due to adverse events, feedback from the healthcare professionals/users etc??
Make sure you indicate whether you are asking to change the number of devices, patients or sites being authorized compared to the original ITA application. If you are changing any of those numbers, explain why.
Health Canada finally came out with a revised ITA guidance document last October to replace the draft 1998 version that had been in effect until then (
Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary - Canada.ca). There is some information regarding "amendments" in this new guidance in Section 2.5. The reason why I have "amendment" in quotes is because there is no official mechanism to amend an existing ITA in the regulations.
Please note that more than likely if there is a change to the device that requires V&V testing, a new authorization number will be issued for the study. You will also likely need to obtain REB approval again for these changes and although you do not have to provide Health Canada with a copy of the REB approval prior to getting your ITA authorization letter (also a new change for Class III and IV devices in 2018), you are required to have it on record prior to implementing the change in the study.
I hope this helps.
Shirley
------------------------------
Shirley Furesz, Ph.D., RAC
Director, Regulatory Affairs Medical Devices
TPIreg, a Division of Innomar Strategies Inc.
Oakville, ON
905.847.4310 ext 6328
sfuresz@tpireg.com------------------------------
Original Message:
Sent: 11-Jan-2019 23:27
From: Anonymous Member
Subject: Canadian Investigational Testing Authorization (ITA)
This message was posted by a user wishing to remain anonymous
Hi,
Has anyone in this forum had experience with Canadian ITA applications? If a company has modifications to the design of the device that currently has authorization, other than redoing the battery of V&V tests, what else needs to be included in the ITA revision request? I know for revised study protocols, we have to keep the tracked changes on. This may be an administrative question; what about in the rest of the application where changes are made to the device description, would they accept an updated application with all tracked changes on?
If anyone has experience they can share, I would appreciate it.
Thanks.