Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone,

Quick question about release notes that are a part of the labeling material (NOT the revision level history log sent during a submission) for an SaMD - do we send a draft of these notes in a 510(k) submission? I recently started at a company that is prepping their first 510(k) (traditional), and this is part of the checklist. My previous company did not send the draft release notes to the FDA as a part of special 510(k)s.

I am of the opinion that these release notes are not required for a pre-marketing submission, because release notes would be information about changes to an approved product, which is not applicable here. Would like to hear what everyone thinks.

Looking forward to hearing from you.
Cheers.

Good day Anon,

In the 510(k) submission there is not really a need to provide the full release notes.  What is needed (and described in the guidance document) is the revision history log.  This revision history log should of course be synced to the release notes.  The revision history log should be detailed enough for the reviewer to understand changes made during the development and lifecycle of the software.  And you are correct typically release notes are post launch/post submission as this is information conveyed to the users on the changes to the product.  They will look to see how you manage the lifecycle and release of versions through your software development environment (procedure).

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 10-May-2022 20:42
From: Anonymous Member
Subject: SaMD Release Notes

This message was posted by a user wishing to remain anonymous

Hello everyone,

Quick question about release notes that are a part of the labeling material (NOT the revision level history log sent during a submission) for an SaMD - do we send a draft of these notes in a 510(k) submission? I recently started at a company that is prepping their first 510(k) (traditional), and this is part of the checklist. My previous company did not send the draft release notes to the FDA as a part of special 510(k)s.

I am of the opinion that these release notes are not required for a pre-marketing submission, because release notes would be information about changes to an approved product, which is not applicable here. Would like to hear what everyone thinks.

Looking forward to hearing from you.
Cheers.

This message was posted by a user wishing to remain anonymous

Hi Richard,

Thank you for the concise answer. To expand on Anon1's question - the startup where I'm working at is implementing 62304 and design controls after development of the SaMD (we don't have design review for the user/software requirements yet, but have a working version of the software), and as such, I don't have an expectation that there will be significant revisions to go into the history log. What should a company do in this scenario? 

Thanks in advance
Original Message:
Sent: 12-May-2022 03:49
From: Richard Vincins
Subject: SaMD Release Notes

Good day Anon,

In the 510(k) submission there is not really a need to provide the full release notes.  What is needed (and described in the guidance document) is the revision history log.  This revision history log should of course be synced to the release notes.  The revision history log should be detailed enough for the reviewer to understand changes made during the development and lifecycle of the software.  And you are correct typically release notes are post launch/post submission as this is information conveyed to the users on the changes to the product.  They will look to see how you manage the lifecycle and release of versions through your software development environment (procedure).

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 10-May-2022 20:42
From: Anonymous Member
Subject: SaMD Release Notes

This message was posted by a user wishing to remain anonymous

Hello everyone,

Quick question about release notes that are a part of the labeling material (NOT the revision level history log sent during a submission) for an SaMD - do we send a draft of these notes in a 510(k) submission? I recently started at a company that is prepping their first 510(k) (traditional), and this is part of the checklist. My previous company did not send the draft release notes to the FDA as a part of special 510(k)s.

I am of the opinion that these release notes are not required for a pre-marketing submission, because release notes would be information about changes to an approved product, which is not applicable here. Would like to hear what everyone thinks.

Looking forward to hearing from you.
Cheers.

Hello there,

I can not speak definitively, but often for "new" software in the 510(k) Revision History content just start at version 1.0 or something similar.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 13-May-2022 15:53
From: Anonymous Member
Subject: SaMD Release Notes

This message was posted by a user wishing to remain anonymous

Hi Richard,

Thank you for the concise answer. To expand on Anon1's question - the startup where I'm working at is implementing 62304 and design controls after development of the SaMD (we don't have design review for the user/software requirements yet, but have a working version of the software), and as such, I don't have an expectation that there will be significant revisions to go into the history log. What should a company do in this scenario?

Thanks in advance
Original Message:
Sent: 12-May-2022 03:49
From: Richard Vincins
Subject: SaMD Release Notes

Good day Anon,

In the 510(k) submission there is not really a need to provide the full release notes.  What is needed (and described in the guidance document) is the revision history log.  This revision history log should of course be synced to the release notes.  The revision history log should be detailed enough for the reviewer to understand changes made during the development and lifecycle of the software.  And you are correct typically release notes are post launch/post submission as this is information conveyed to the users on the changes to the product.  They will look to see how you manage the lifecycle and release of versions through your software development environment (procedure).

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 10-May-2022 20:42
From: Anonymous Member
Subject: SaMD Release Notes

This message was posted by a user wishing to remain anonymous

Hello everyone,

Quick question about release notes that are a part of the labeling material (NOT the revision level history log sent during a submission) for an SaMD - do we send a draft of these notes in a 510(k) submission? I recently started at a company that is prepping their first 510(k) (traditional), and this is part of the checklist. My previous company did not send the draft release notes to the FDA as a part of special 510(k)s.

I am of the opinion that these release notes are not required for a pre-marketing submission, because release notes would be information about changes to an approved product, which is not applicable here. Would like to hear what everyone thinks.

Looking forward to hearing from you.
Cheers.