Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​​Dear RAPS members,

I am currently working on a new medical device license application for marketing license in Canada. This is a hardware+ software based class 3 device.

While I am still working on this application I hear that a new software patch release is coming up. I need some advise on how to address the patch information in the application.  Will it be advisable to add the verification and validation data of the original new medical device and the latest patch VNV data or limit it to latest patch VNV data which may not include the VNV data for the original device we intended to license.

What should be an ideal approach when your actual device license application get's a patch before you could sent it to the agency?

Just send in the "current state" of the product.  So if the software is at version 1.0 and this "patch" brings it to version 1.2, then submit version 1.2 in the MDL.  Just keep in mind that there should be a software version history that details changes to the software through the entire life cycle.  The verification and validation testing that was performed to version 1.2 may need to include additional documentation from version 1.0 if there is limited V&V testing on version 1.2.  Just note that you may need to submit enough software documentation from version 1.0 and version 1.2 (pre-patch and post-patch in your instance) to make sure the entire software is described.  Make sure there is enough information in the MDL that shows complete testing of software supporting typical safety and performance requirements; those that would be outlined or required from a standard like IEC 62304.

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 15-Mar-2018 20:27
From: Anonymous Member
Subject: New medical device license application Canada

This message was posted by a user wishing to remain anonymous

​​Dear RAPS members,

I am currently working on a new medical device license application for marketing license in Canada. This is a hardware+ software based class 3 device.

While I am still working on this application I hear that a new software patch release is coming up. I need some advise on how to address the patch information in the application.  Will it be advisable to add the verification and validation data of the original new medical device and the latest patch VNV data or limit it to latest patch VNV data which may not include the VNV data for the original device we intended to license.

What should be an ideal approach when your actual device license application get's a patch before you could sent it to the agency?