Regulatory Open Forum

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

Shimon,

A 510(k) application is intended for a product to be marketed for a specific intended purpose assisting in diagnosis, monitoring, and treatment of a disease condition.  So while there is nothing forbidden this, if you look at 21 CFR 807 and The Act, the purpose of pre-market notification is to market a device for its intended use - might be a stretch for only research use purposes.  There may be some situations where devices can also be cleared for market and used for clinical research purposes - in order to report the results to patients - instead of not reporting if a pure research device.  There may be other circumstances such as combination products.  However, you would have to give specific device type and intended use to provide any further context.

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

Thanks Richard,

So have a look at https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152749.pdf

In your opinion, the purpose of such a clearing is to support clinical trials / proof of concept?

It's very odd that a manufacturer choses to invest so much money for a very narrow use.

Also, how does FDA reviewers deal with such an application? i.e. is there less scrutiny? (seems unlikely)

Thanks!

Shimon

Shimon,

A 510(k) application is intended for a product to be marketed for a specific intended purpose assisting in diagnosis, monitoring, and treatment of a disease condition.  So while there is nothing forbidden this, if you look at 21 CFR 807 and The Act, the purpose of pre-market notification is to market a device for its intended use - might be a stretch for only research use purposes.  There may be some situations where devices can also be cleared for market and used for clinical research purposes - in order to report the results to patients - instead of not reporting if a pure research device.  There may be other circumstances such as combination products.  However, you would have to give specific device type and intended use to provide any further context.

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

Shimon,

I am not familiar with this technology and clinical application, so I would say the intended use might be limiting the type of application being used.  There is not less scrutiny by FDA, though maybe with thorough clinical data, e.g. a clinical trial, there can not be claims made for a clinical application.  A company would have to weigh the costs versus benefit of certain intended use statements to see if would be viable for them.

Thanks Richard,

So have a look at https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152749.pdf

In your opinion, the purpose of such a clearing is to support clinical trials / proof of concept?

It's very odd that a manufacturer choses to invest so much money for a very narrow use.

Also, how does FDA reviewers deal with such an application? i.e. is there less scrutiny? (seems unlikely)

Thanks!

Shimon

Shimon,

A 510(k) application is intended for a product to be marketed for a specific intended purpose assisting in diagnosis, monitoring, and treatment of a disease condition.  So while there is nothing forbidden this, if you look at 21 CFR 807 and The Act, the purpose of pre-market notification is to market a device for its intended use - might be a stretch for only research use purposes.  There may be some situations where devices can also be cleared for market and used for clinical research purposes - in order to report the results to patients - instead of not reporting if a pure research device.  There may be other circumstances such as combination products.  However, you would have to give specific device type and intended use to provide any further context.

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

Note that the device you have identified provides quantitative data. When some other manufacturer/sponsor is conducting a clinical study or pre-clinical study using this device (i.e., K152749) and when the data is submitted as part of a pre-market clearance, the reviewers would want to know how the flow data (i.e., quantitative measurement) was validated.  In such scenarios, it is easier for the sponsor to point to a commercially available cleared device (such as K152749).  Since the device described in K152749 is available in 3 different renditions, my guess is that these models were specifically created to be used for clinical studies or pre-clinical studies.

There may be other reasons as well...

Original Message:
Sent: 20-Sep-2023 07:06
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

Note that the device you have identified provides quantitative data. When some other manufacturer/sponsor is conducting a clinical study or pre-clinical study using this device (i.e., K152749) and when the data is submitted as part of a pre-market clearance, the reviewers would want to know how the flow data (i.e., quantitative measurement) was validated.  In such scenarios, it is easier for the sponsor to point to a commercially available cleared device (such as K152749).  Since the device described in K152749 is available in 3 different renditions, my guess is that these models were specifically created to be used for clinical studies or pre-clinical studies.

There may be other reasons as well...

Original Message:
Sent: 20-Sep-2023 07:06
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

Thank you, that makes perfect sense!

I can only imagine that the FDA review process would be somewhat different - minimum risks, minimal IFU, bench testing, no usability and no clinical data. 

Shimon

Note that the device you have identified provides quantitative data. When some other manufacturer/sponsor is conducting a clinical study or pre-clinical study using this device (i.e., K152749) and when the data is submitted as part of a pre-market clearance, the reviewers would want to know how the flow data (i.e., quantitative measurement) was validated.  In such scenarios, it is easier for the sponsor to point to a commercially available cleared device (such as K152749).  Since the device described in K152749 is available in 3 different renditions, my guess is that these models were specifically created to be used for clinical studies or pre-clinical studies.

There may be other reasons as well...

Original Message:
Sent: 20-Sep-2023 07:06
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

I would doubt that the FDA would take a minimalistic approach. Since there is a laser involved, the safety concerns will be there and hence demonstrating conformity to basic safety, EMC, laser power/classification, etc. will apply. Being a quantitative device, the linearity over flow rates, blood vessel size vessel/blood flow direction, etc. will have to be proven. Usability could come into play if the blood flow reported is indeed dependent on the orientation of the device or how it is held in place (i.e., by hand, or attached to a stand, etc.). Clinical data will not be required but side-by-side comparison with the predicate will most likely be required.

Potentially cybersecurity...if there is a concern that the data calculated or reported could be compromised.

Original Message:
Sent: 24-Sep-2023 03:34
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Thank you, that makes perfect sense!

I can only imagine that the FDA review process would be somewhat different - minimum risks, minimal IFU, bench testing, no usability and no clinical data. 

Shimon

Note that the device you have identified provides quantitative data. When some other manufacturer/sponsor is conducting a clinical study or pre-clinical study using this device (i.e., K152749) and when the data is submitted as part of a pre-market clearance, the reviewers would want to know how the flow data (i.e., quantitative measurement) was validated.  In such scenarios, it is easier for the sponsor to point to a commercially available cleared device (such as K152749).  Since the device described in K152749 is available in 3 different renditions, my guess is that these models were specifically created to be used for clinical studies or pre-clinical studies.

There may be other reasons as well...

Original Message:
Sent: 20-Sep-2023 07:06
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

I would doubt that the FDA would take a minimalistic approach. Since there is a laser involved, the safety concerns will be there and hence demonstrating conformity to basic safety, EMC, laser power/classification, etc. will apply. Being a quantitative device, the linearity over flow rates, blood vessel size vessel/blood flow direction, etc. will have to be proven. Usability could come into play if the blood flow reported is indeed dependent on the orientation of the device or how it is held in place (i.e., by hand, or attached to a stand, etc.). Clinical data will not be required but side-by-side comparison with the predicate will most likely be required.

Potentially cybersecurity...if there is a concern that the data calculated or reported could be compromised.

Original Message:
Sent: 24-Sep-2023 03:34
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Thank you, that makes perfect sense!

I can only imagine that the FDA review process would be somewhat different - minimum risks, minimal IFU, bench testing, no usability and no clinical data. 

Shimon

Note that the device you have identified provides quantitative data. When some other manufacturer/sponsor is conducting a clinical study or pre-clinical study using this device (i.e., K152749) and when the data is submitted as part of a pre-market clearance, the reviewers would want to know how the flow data (i.e., quantitative measurement) was validated.  In such scenarios, it is easier for the sponsor to point to a commercially available cleared device (such as K152749).  Since the device described in K152749 is available in 3 different renditions, my guess is that these models were specifically created to be used for clinical studies or pre-clinical studies.

There may be other reasons as well...

Original Message:
Sent: 20-Sep-2023 07:06
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

The laser shouldn't be an issue, since even as an exempt research device 21CFR1040 applies, and FDA generally uses those same safety requirements for medical lasers.

I would expect the biggest thing to establish would be the precision/accuracy and, as someone else said, whether human factors have an impact or not.

Ginger

I would doubt that the FDA would take a minimalistic approach. Since there is a laser involved, the safety concerns will be there and hence demonstrating conformity to basic safety, EMC, laser power/classification, etc. will apply. Being a quantitative device, the linearity over flow rates, blood vessel size vessel/blood flow direction, etc. will have to be proven. Usability could come into play if the blood flow reported is indeed dependent on the orientation of the device or how it is held in place (i.e., by hand, or attached to a stand, etc.). Clinical data will not be required but side-by-side comparison with the predicate will most likely be required.

Potentially cybersecurity...if there is a concern that the data calculated or reported could be compromised.

Original Message:
Sent: 24-Sep-2023 03:34
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Thank you, that makes perfect sense!

I can only imagine that the FDA review process would be somewhat different - minimum risks, minimal IFU, bench testing, no usability and no clinical data. 

Shimon

Note that the device you have identified provides quantitative data. When some other manufacturer/sponsor is conducting a clinical study or pre-clinical study using this device (i.e., K152749) and when the data is submitted as part of a pre-market clearance, the reviewers would want to know how the flow data (i.e., quantitative measurement) was validated.  In such scenarios, it is easier for the sponsor to point to a commercially available cleared device (such as K152749).  Since the device described in K152749 is available in 3 different renditions, my guess is that these models were specifically created to be used for clinical studies or pre-clinical studies.

There may be other reasons as well...

Original Message:
Sent: 20-Sep-2023 07:06
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon

Note that the device you have identified provides quantitative data. When some other manufacturer/sponsor is conducting a clinical study or pre-clinical study using this device (i.e., K152749) and when the data is submitted as part of a pre-market clearance, the reviewers would want to know how the flow data (i.e., quantitative measurement) was validated.  In such scenarios, it is easier for the sponsor to point to a commercially available cleared device (such as K152749).  Since the device described in K152749 is available in 3 different renditions, my guess is that these models were specifically created to be used for clinical studies or pre-clinical studies.

There may be other reasons as well...

Original Message:
Sent: 20-Sep-2023 07:06
From: Shimon Vaknin
Subject: 510(k) application for research purposes

Hello Cove dwellers,

Recently one CEO approached me with a request to run a 510(k) application for research only purposes. 

I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says: "[...] It is intended to be used for clinical research applications and pre-clinical research application".

Have any of you accompanies such an application?  it's not clear to me how and why should FDA deal with such an application, and what level of scrutiny they apply?

Thanks for your input!!

Shimon