Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.

Hello Anon,

If indeed you are going through the Special 510(k) pathway and qualify for this, then the regulatory submission takes on more a "yes it was done" aspect.  Assuming you did biocompatibility again means maybe a material change has occurred or been affected by the change.  The whole premise of a Special 510(k) is changes have been made considered significant, but essentially it is still your device and those changes have only raised some issues concerned safety and performance.  It depends highly on the reviewer, but I have submitted Special 510(k)s with just the report results - no report and been accepted; yet other times they asked for the full report.  If this is about timing, you could submit with the justification "promising" the study will be complete.  As a Special 510(k) it might go through the Refuse to Accept fine and you might not need the actual report, though I could not comment fully without knowing the type of changes.  Worst is you can try, does not pass the RTA which you have 180 days to respond which would put you in next February's timeframe.

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

Original Message:
Sent: 19-Nov-2020 16:25
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.

Hi Anon,

In my experience, if there is a need to submit a full test report to demonstrate substantial equivalence in a Special 510(k), it is likely that FDA will convert the submission to a Traditional 510(k).

This aligns with statements in the FDA guidance for Special 510(k)s, such as:

"Complete test reports should not be submitted in a Special 510(k). If complete test reports are submitted, FDA intends to assess whether the information can be reviewed in a summary format before converting to a Traditional 510(k)."

and

"When FDA does not agree that the performance data can be summarized, FDA intends to convert the submission to a Traditional 510(k)."

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 20-Nov-2020 01:09
From: Richard Vincins
Subject: Special 510K Submission

Hello Anon,

If indeed you are going through the Special 510(k) pathway and qualify for this, then the regulatory submission takes on more a "yes it was done" aspect.  Assuming you did biocompatibility again means maybe a material change has occurred or been affected by the change.  The whole premise of a Special 510(k) is changes have been made considered significant, but essentially it is still your device and those changes have only raised some issues concerned safety and performance.  It depends highly on the reviewer, but I have submitted Special 510(k)s with just the report results - no report and been accepted; yet other times they asked for the full report.  If this is about timing, you could submit with the justification "promising" the study will be complete.  As a Special 510(k) it might go through the Refuse to Accept fine and you might not need the actual report, though I could not comment fully without knowing the type of changes.  Worst is you can try, does not pass the RTA which you have 180 days to respond which would put you in next February's timeframe.

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

Original Message:
Sent: 19-Nov-2020 16:25
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.

If you require something more than summary reports FDA will RTA and request a traditional route. Good news is this happens early in the review.

------------------------------
Edward Panek
VP, QA/RA
Med Device

DOD/DARPA/Dept Veterans Affairs Design Controls in Research

Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 20-Nov-2020 06:10
From: Roger Gray
Subject: Special 510K Submission

Hi Anon,

In my experience, if there is a need to submit a full test report to demonstrate substantial equivalence in a Special 510(k), it is likely that FDA will convert the submission to a Traditional 510(k).

This aligns with statements in the FDA guidance for Special 510(k)s, such as:

"Complete test reports should not be submitted in a Special 510(k). If complete test reports are submitted, FDA intends to assess whether the information can be reviewed in a summary format before converting to a Traditional 510(k)."

and

"When FDA does not agree that the performance data can be summarized, FDA intends to convert the submission to a Traditional 510(k)."

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 20-Nov-2020 01:09
From: Richard Vincins
Subject: Special 510K Submission

Hello Anon,

If indeed you are going through the Special 510(k) pathway and qualify for this, then the regulatory submission takes on more a "yes it was done" aspect.  Assuming you did biocompatibility again means maybe a material change has occurred or been affected by the change.  The whole premise of a Special 510(k) is changes have been made considered significant, but essentially it is still your device and those changes have only raised some issues concerned safety and performance.  It depends highly on the reviewer, but I have submitted Special 510(k)s with just the report results - no report and been accepted; yet other times they asked for the full report.  If this is about timing, you could submit with the justification "promising" the study will be complete.  As a Special 510(k) it might go through the Refuse to Accept fine and you might not need the actual report, though I could not comment fully without knowing the type of changes.  Worst is you can try, does not pass the RTA which you have 180 days to respond which would put you in next February's timeframe.

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

Original Message:
Sent: 19-Nov-2020 16:25
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.

Hello Anon


Sorry to be the bearer if bad news, but nobody in these replies has mentioned the elephant in the room.  Please read the Special 510k Guidance document.

A Special 510k requires the Sponsor to create and sign a statement that all required Design Control activities were undertaken by the designated individuals responsible and are complete and that the records  are available for review. The actual wording is in the guidance.  

You also have to sign and submit the Truthful and Accuracy statement.   

The Biocomp testing is a design control activity.  If you submit before testing is complete, you are in effect lying on both required statements.

Just my 2 cents.  I would rethink that approach, and my bet is with that much testing, it has a high probability of conversion. But ultimately it is your business risk.


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

Original Message:
Sent: 20-Nov-2020 06:10
From: Roger Gray
Subject: Special 510K Submission

Hi Anon,

In my experience, if there is a need to submit a full test report to demonstrate substantial equivalence in a Special 510(k), it is likely that FDA will convert the submission to a Traditional 510(k).

This aligns with statements in the FDA guidance for Special 510(k)s, such as:

"Complete test reports should not be submitted in a Special 510(k). If complete test reports are submitted, FDA intends to assess whether the information can be reviewed in a summary format before converting to a Traditional 510(k)."

and

"When FDA does not agree that the performance data can be summarized, FDA intends to convert the submission to a Traditional 510(k)."

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 20-Nov-2020 01:09
From: Richard Vincins
Subject: Special 510K Submission

Hello Anon,

If indeed you are going through the Special 510(k) pathway and qualify for this, then the regulatory submission takes on more a "yes it was done" aspect.  Assuming you did biocompatibility again means maybe a material change has occurred or been affected by the change.  The whole premise of a Special 510(k) is changes have been made considered significant, but essentially it is still your device and those changes have only raised some issues concerned safety and performance.  It depends highly on the reviewer, but I have submitted Special 510(k)s with just the report results - no report and been accepted; yet other times they asked for the full report.  If this is about timing, you could submit with the justification "promising" the study will be complete.  As a Special 510(k) it might go through the Refuse to Accept fine and you might not need the actual report, though I could not comment fully without knowing the type of changes.  Worst is you can try, does not pass the RTA which you have 180 days to respond which would put you in next February's timeframe.

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

Original Message:
Sent: 19-Nov-2020 16:25
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.

This is a huge point. In the Special 510(k) you certify that all V&V activity is complete and meets criteria. In a traditional 510(k) that is not required (only certification that the info included is truthful and accurate). Thus, when there is a long lagging V&V test (be it biocomp or often packaging), it can at times be more beneficial to the timeline to submit a Traditional 510(k) rather than a Special. Otherwise, you do need to wait to have the data for the Special. That or lie to the FDA, but lying to the FDA is one of the ways even a "worker bee" RA person (and not just executives in control) can get in big trouble if it is found out, so I really wouldn't advise it.

the other ginger...


------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 21-Nov-2020 08:12
From: Ginger Cantor
Subject: Special 510K Submission

Hello Anon


Sorry to be the bearer if bad news, but nobody in these replies has mentioned the elephant in the room.  Please read the Special 510k Guidance document.

A Special 510k requires the Sponsor to create and sign a statement that all required Design Control activities were undertaken by the designated individuals responsible and are complete and that the records  are available for review. The actual wording is in the guidance.

You also have to sign and submit the Truthful and Accuracy statement.

The Biocomp testing is a design control activity.  If you submit before testing is complete, you are in effect lying on both required statements.

Just my 2 cents.  I would rethink that approach, and my bet is with that much testing, it has a high probability of conversion. But ultimately it is your business risk.


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

Original Message:
Sent: 20-Nov-2020 06:10
From: Roger Gray
Subject: Special 510K Submission

Hi Anon,

In my experience, if there is a need to submit a full test report to demonstrate substantial equivalence in a Special 510(k), it is likely that FDA will convert the submission to a Traditional 510(k).

This aligns with statements in the FDA guidance for Special 510(k)s, such as:

"Complete test reports should not be submitted in a Special 510(k). If complete test reports are submitted, FDA intends to assess whether the information can be reviewed in a summary format before converting to a Traditional 510(k)."

and

"When FDA does not agree that the performance data can be summarized, FDA intends to convert the submission to a Traditional 510(k)."

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 20-Nov-2020 01:09
From: Richard Vincins
Subject: Special 510K Submission

Hello Anon,

If indeed you are going through the Special 510(k) pathway and qualify for this, then the regulatory submission takes on more a "yes it was done" aspect.  Assuming you did biocompatibility again means maybe a material change has occurred or been affected by the change.  The whole premise of a Special 510(k) is changes have been made considered significant, but essentially it is still your device and those changes have only raised some issues concerned safety and performance.  It depends highly on the reviewer, but I have submitted Special 510(k)s with just the report results - no report and been accepted; yet other times they asked for the full report.  If this is about timing, you could submit with the justification "promising" the study will be complete.  As a Special 510(k) it might go through the Refuse to Accept fine and you might not need the actual report, though I could not comment fully without knowing the type of changes.  Worst is you can try, does not pass the RTA which you have 180 days to respond which would put you in next February's timeframe.

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

Original Message:
Sent: 19-Nov-2020 16:25
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.

Specials require an attestation that design control has been completed. I would wait until you have signed off on all phases so that you can attest to that accurately, which will include having all biocompatibility testing done. You don't have to submit complete reports, but you will have to state that it is biocompatible and what tests you did. If a test isn't complete, design control isn't complete.

Edit: Ha, I see I'm repeating Ginger.

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States
------------------------------

Original Message:
Sent: 19-Nov-2020 16:25
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.

This message was posted by a user wishing to remain anonymous

Thank you to everyone who responded! I am not the original person who posted this question, but I found this thread while trying to confirm the same thing (that in order to submit a Special all testing has to be complete).

What is your experience with a Traditional 510(k) - can that be submitted before all the testing is completed?
If possible then how would you go about submitting a Traditional without all the V&V testing? (in particular packaging validation is going to be delayed in my case but maybe even more tests)

Thank you!
Anon.
Original Message:
Sent: 21-Nov-2020 11:00
From: Corey Jaseph
Subject: Special 510K Submission

Specials require an attestation that design control has been completed. I would wait until you have signed off on all phases so that you can attest to that accurately, which will include having all biocompatibility testing done. You don't have to submit complete reports, but you will have to state that it is biocompatible and what tests you did. If a test isn't complete, design control isn't complete.

Edit: Ha, I see I'm repeating Ginger.

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States

Original Message:
Sent: 19-Nov-2020 16:25
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.

Hey Anon,

Generally if I know something is not complete in a traditional 510(k), I either include a protocol and a statement that it will pass before placing on the market, or I simply include the "final criteria" using future tense. For instance, "Sterilization will be via EtO per <standard>. SAL will be 10 -6."

As to which, it depends on the test. With things like sterilization and shipping/handling, where there are well established standards, it often works just to say that. If the test is more complex and specific to the device, the protocol can be helpful.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 03-Dec-2020 00:30
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Thank you to everyone who responded! I am not the original person who posted this question, but I found this thread while trying to confirm the same thing (that in order to submit a Special all testing has to be complete).

What is your experience with a Traditional 510(k) - can that be submitted before all the testing is completed?
If possible then how would you go about submitting a Traditional without all the V&V testing? (in particular packaging validation is going to be delayed in my case but maybe even more tests)

Thank you!
Anon.
Original Message:
Sent: 21-Nov-2020 11:00
From: Corey Jaseph
Subject: Special 510K Submission

Specials require an attestation that design control has been completed. I would wait until you have signed off on all phases so that you can attest to that accurately, which will include having all biocompatibility testing done. You don't have to submit complete reports, but you will have to state that it is biocompatible and what tests you did. If a test isn't complete, design control isn't complete.

Edit: Ha, I see I'm repeating Ginger.

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States

Original Message:
Sent: 19-Nov-2020 16:25
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.

This message was posted by a user wishing to remain anonymous

Thank you for the response Ginger!
Original Message:
Sent: 09-Dec-2020 08:52
From: Ginger Glaser
Subject: Special 510K Submission

Hey Anon,

Generally if I know something is not complete in a traditional 510(k), I either include a protocol and a statement that it will pass before placing on the market, or I simply include the "final criteria" using future tense. For instance, "Sterilization will be via EtO per <standard>. SAL will be 10 -6."

As to which, it depends on the test. With things like sterilization and shipping/handling, where there are well established standards, it often works just to say that. If the test is more complex and specific to the device, the protocol can be helpful.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 03-Dec-2020 00:30
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Thank you to everyone who responded! I am not the original person who posted this question, but I found this thread while trying to confirm the same thing (that in order to submit a Special all testing has to be complete).

What is your experience with a Traditional 510(k) - can that be submitted before all the testing is completed?
If possible then how would you go about submitting a Traditional without all the V&V testing? (in particular packaging validation is going to be delayed in my case but maybe even more tests)

Thank you!
Anon.
Original Message:
Sent: 21-Nov-2020 11:00
From: Corey Jaseph
Subject: Special 510K Submission

Specials require an attestation that design control has been completed. I would wait until you have signed off on all phases so that you can attest to that accurately, which will include having all biocompatibility testing done. You don't have to submit complete reports, but you will have to state that it is biocompatible and what tests you did. If a test isn't complete, design control isn't complete.

Edit: Ha, I see I'm repeating Ginger.

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States

Original Message:
Sent: 19-Nov-2020 16:25
From: Anonymous Member
Subject: Special 510K Submission

This message was posted by a user wishing to remain anonymous

Hi,

We are ready to submit a special 510K to the FDA and the only biocompatibility report which we are missing is the "subchronic toxicity" report, which is not expected until February.  Nonetheless, the animals have been exposed and now their tissue slices need to be examined, no animals have died, so we are confident in the results.

Can we continue with our special 510K with a rationale for this report?  The material has been previously cleared with biocompatibility using a similar device.