This message was posted by a user wishing to remain anonymous
Hi everyone,
I am working on an amendment of a current investigational testing authorization. I have some questions regarding design changes for an IDE or ITA. The original device received an ITA authorization, but during the time of development, there were no design controls. In Canada, according to the guidance for ITA, a QMS is recommended but not required for investigational device development so there was no QMS for this project at all. For the amendment to the original ITA, however, a group has made some design changes but is not sure what design changes to include in the amendment if some parts of the device that were changed were not mentioned in the original application. Has somebody come across this scenario? I would like some guidance.
Thanks