Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few.

62304- ANSI AAMI IEC 62304:2006/A1:2016
62366-1:2015- Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
14971-Medical Devices - Applications Of Risk Management To Medical Devices


I am trying to see what approach will be good. Should I prepare a DOC or just list these as general use standards? The latest guidance on voluntary consensus standards states "When a manufacturer is citing the general use of a voluntary consensus standard, we recommend that the basis of such use be included along with the underlying information or data that supports how the standard was used."

The standards that we have  are general standards with no data generated as a result of use of such standards. Not sure how to approach this. Will it be OK if I just list the standards in the DOC/standards section (9) of the submission and mention that the device has no special controls therefore, no specific standard has been used but a list of general standards used for the device is provided.

Thanks!

This message was posted by a user wishing to remain anonymous

I'd recommend a statement that you are using these standards as general use. A Declaration of Conformity allows you to submit less testing information, but FDA still may request it. In the case of the standards you mentioned, FDA will require that information (e.g. software documentation, risk management, etc). So I would not bother with the DoC as you still have to submit all that material.

Here was a nice thread discussing the topic from last month: https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=c9f6d83d-230d-4386-a72f-dff138a18c8c&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmc9f6d83d-230d-4386-a72f-dff138a18c8c
Original Message:
Sent: 07-May-2020 01:50
From: Anonymous Member
Subject: FDA DOC vs general use of consensus standard

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few.

62304- ANSI AAMI IEC 62304:2006/A1:2016
62366-1:2015- Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
14971-Medical Devices - Applications Of Risk Management To Medical Devices


I am trying to see what approach will be good. Should I prepare a DOC or just list these as general use standards? The latest guidance on voluntary consensus standards states "When a manufacturer is citing the general use of a voluntary consensus standard, we recommend that the basis of such use be included along with the underlying information or data that supports how the standard was used."

The standards that we have  are general standards with no data generated as a result of use of such standards. Not sure how to approach this. Will it be OK if I just list the standards in the DOC/standards section (9) of the submission and mention that the device has no special controls therefore, no specific standard has been used but a list of general standards used for the device is provided.

Thanks!

Hello Anonymous 

You will be generating software documents (which is data of a sort), in accordance  with  ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission.   I just think DoCs are wasteful busy time and would do as few as possible.

Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device  usability  study is not required in a submission don't  put it in there unless asked.  Just my opinion.

Biocompatibility if used, is generating test data in accordance with ISO 10993-1, as will EMC, per the EMC Standard IEC 60601-1-2.

Good luck!

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 07-May-2020 01:50
From: Anonymous Member
Subject: FDA DOC vs general use of consensus standard

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few.

62304- ANSI AAMI IEC 62304:2006/A1:2016
62366-1:2015- Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
14971-Medical Devices - Applications Of Risk Management To Medical Devices


I am trying to see what approach will be good. Should I prepare a DOC or just list these as general use standards? The latest guidance on voluntary consensus standards states "When a manufacturer is citing the general use of a voluntary consensus standard, we recommend that the basis of such use be included along with the underlying information or data that supports how the standard was used."

The standards that we have  are general standards with no data generated as a result of use of such standards. Not sure how to approach this. Will it be OK if I just list the standards in the DOC/standards section (9) of the submission and mention that the device has no special controls therefore, no specific standard has been used but a list of general standards used for the device is provided.

Thanks!

Hello,

I agree with Ginger, when you look at standards there will most likely be an output of documents from following those standards, i.e. risk management file, usability report, all the software documentation.  These would be included in the different sections of the 510(k) so you can claim them as recognised standards you are following.  I have mentioned in previous posts, we take a simple approach for the declaration of conformity to standards that is a small table describing what we are complying, what sections or all of the standard, and how these are being reported in the standard such as IEC 62304 software documents in Section 16.  I commonly have references to 8 or 10 recognised standards and my Section 9 section is only 2 to 3 pages.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 08-May-2020 05:42
From: Ginger Cantor
Subject: FDA DOC vs general use of consensus standard

Hello Anonymous

You will be generating software documents (which is data of a sort), in accordance  with  ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission.   I just think DoCs are wasteful busy time and would do as few as possible.

Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device  usability  study is not required in a submission don't  put it in there unless asked.  Just my opinion.

Biocompatibility if used, is generating test data in accordance with ISO 10993-1, as will EMC, per the EMC Standard IEC 60601-1-2.

Good luck!

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 07-May-2020 01:50
From: Anonymous Member
Subject: FDA DOC vs general use of consensus standard

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few.

62304- ANSI AAMI IEC 62304:2006/A1:2016
62366-1:2015- Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
14971-Medical Devices - Applications Of Risk Management To Medical Devices


I am trying to see what approach will be good. Should I prepare a DOC or just list these as general use standards? The latest guidance on voluntary consensus standards states "When a manufacturer is citing the general use of a voluntary consensus standard, we recommend that the basis of such use be included along with the underlying information or data that supports how the standard was used."

The standards that we have  are general standards with no data generated as a result of use of such standards. Not sure how to approach this. Will it be OK if I just list the standards in the DOC/standards section (9) of the submission and mention that the device has no special controls therefore, no specific standard has been used but a list of general standards used for the device is provided.

Thanks!

This message was posted by a user wishing to remain anonymous

Thank you all. This is very helpful.
Original Message:
Sent: 09-May-2020 03:13
From: Richard Vincins
Subject: FDA DOC vs general use of consensus standard

Hello,

I agree with Ginger, when you look at standards there will most likely be an output of documents from following those standards, i.e. risk management file, usability report, all the software documentation.  These would be included in the different sections of the 510(k) so you can claim them as recognised standards you are following.  I have mentioned in previous posts, we take a simple approach for the declaration of conformity to standards that is a small table describing what we are complying, what sections or all of the standard, and how these are being reported in the standard such as IEC 62304 software documents in Section 16.  I commonly have references to 8 or 10 recognised standards and my Section 9 section is only 2 to 3 pages.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 08-May-2020 05:42
From: Ginger Cantor
Subject: FDA DOC vs general use of consensus standard

Hello Anonymous

You will be generating software documents (which is data of a sort), in accordance  with  ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission.   I just think DoCs are wasteful busy time and would do as few as possible.

Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device  usability  study is not required in a submission don't  put it in there unless asked.  Just my opinion.

Biocompatibility if used, is generating test data in accordance with ISO 10993-1, as will EMC, per the EMC Standard IEC 60601-1-2.

Good luck!

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 07-May-2020 01:50
From: Anonymous Member
Subject: FDA DOC vs general use of consensus standard

This message was posted by a user wishing to remain anonymous

Dear RAPS members,

I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few.

62304- ANSI AAMI IEC 62304:2006/A1:2016
62366-1:2015- Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
14971-Medical Devices - Applications Of Risk Management To Medical Devices


I am trying to see what approach will be good. Should I prepare a DOC or just list these as general use standards? The latest guidance on voluntary consensus standards states "When a manufacturer is citing the general use of a voluntary consensus standard, we recommend that the basis of such use be included along with the underlying information or data that supports how the standard was used."

The standards that we have  are general standards with no data generated as a result of use of such standards. Not sure how to approach this. Will it be OK if I just list the standards in the DOC/standards section (9) of the submission and mention that the device has no special controls therefore, no specific standard has been used but a list of general standards used for the device is provided.

Thanks!