Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all,
is there any FDA guidance on the content and format of clinical investigation protocols and reports for medical devices (class II in our case)?
We are currently using the format of ISO 14155 2020 (as we claim compliance to the standard) but I wonder if there is anything more specific (or additional) that FDA expects. I have always the feeling that FDA likes a more concise style compared to EU. 
Also, is it compulsory to repeat in the report things that were already described in the protocol (e.g., device description, the protocol itself etc.)? Can we simply refer to the protocol or other documents?
Thanks in advance

Hello Anon,

No there is no specified structure for content or format of clinical investigation protocols or reports, but they do have various guidance documents (also on the CDER/CBER side) which might be helpful in creating these documents.  FDA does recognise ISO 14155 with the structure and management of clinical trials.  The content and format of clinical investigation also may depend on the reviewer as they have different experiences and different ways they have seen clinical studies presented.  It is not compulsory to repeat information, but again this largely depends on the reviewer, their understanding, and what information is being presented.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Mar-2022 11:55
From: Anonymous Member
Subject: format clinical protocol and reports for 510k

This message was posted by a user wishing to remain anonymous

Hello all,
is there any FDA guidance on the content and format of clinical investigation protocols and reports for medical devices (class II in our case)?
We are currently using the format of ISO 14155 2020 (as we claim compliance to the standard) but I wonder if there is anything more specific (or additional) that FDA expects. I have always the feeling that FDA likes a more concise style compared to EU.
Also, is it compulsory to repeat in the report things that were already described in the protocol (e.g., device description, the protocol itself etc.)? Can we simply refer to the protocol or other documents?
Thanks in advance

I am not aware of an FDA guidance that is specific for medical devices. I have always followed the ICH E3 guidance as it provides a format that is common across the Agency and is intended to include the elements of the report that are considered helpful for their review. Although there is a tendency in the medical products industry to apply such guidance rigidly, that is not the intent of the Agency as made clear in the ICH E3 Q and A document. I am not familiar with ISO 14155 format but as long as it contains the expected content in an easily reviewable structure, I suppose it should be fine.

In general I prefer to include in one document the key information a reviewer would need for a facilitated review and not make them open another document. I would include device description as key information. My guiding principal is to remember that the report is being written for the reviewer's convenience and not for the author's convenience.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 02-Mar-2022 11:55
From: Anonymous Member
Subject: format clinical protocol and reports for 510k

This message was posted by a user wishing to remain anonymous

Hello all,
is there any FDA guidance on the content and format of clinical investigation protocols and reports for medical devices (class II in our case)?
We are currently using the format of ISO 14155 2020 (as we claim compliance to the standard) but I wonder if there is anything more specific (or additional) that FDA expects. I have always the feeling that FDA likes a more concise style compared to EU.
Also, is it compulsory to repeat in the report things that were already described in the protocol (e.g., device description, the protocol itself etc.)? Can we simply refer to the protocol or other documents?
Thanks in advance

This message was posted by a user wishing to remain anonymous

Thank you all
Original Message:
Sent: 03-Mar-2022 08:58
From: Glen Park
Subject: format clinical protocol and reports for 510k

I am not aware of an FDA guidance that is specific for medical devices. I have always followed the ICH E3 guidance as it provides a format that is common across the Agency and is intended to include the elements of the report that are considered helpful for their review. Although there is a tendency in the medical products industry to apply such guidance rigidly, that is not the intent of the Agency as made clear in the ICH E3 Q and A document. I am not familiar with ISO 14155 format but as long as it contains the expected content in an easily reviewable structure, I suppose it should be fine.

In general I prefer to include in one document the key information a reviewer would need for a facilitated review and not make them open another document. I would include device description as key information. My guiding principal is to remember that the report is being written for the reviewer's convenience and not for the author's convenience.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 02-Mar-2022 11:55
From: Anonymous Member
Subject: format clinical protocol and reports for 510k

This message was posted by a user wishing to remain anonymous

Hello all,
is there any FDA guidance on the content and format of clinical investigation protocols and reports for medical devices (class II in our case)?
We are currently using the format of ISO 14155 2020 (as we claim compliance to the standard) but I wonder if there is anything more specific (or additional) that FDA expects. I have always the feeling that FDA likes a more concise style compared to EU.
Also, is it compulsory to repeat in the report things that were already described in the protocol (e.g., device description, the protocol itself etc.)? Can we simply refer to the protocol or other documents?
Thanks in advance