Regulatory Open Forum

Hello all,

I have a question related to updating the product code in FDA database for a 510(k) device. The device was initially cleared for three specific indications and the firm has decided to market the device for only one of those indications. I understand that this is not required a new 510(k) submission, however, I would like to understand the process of updating the product code in the 510(k) database due to this indication update/change. 

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------

Good day Shikha,

The US FDA's 510(k) database is "written in stone" meaning there are not updates, changes, or amendments which can be made to the database once a product has been cleared.  This is why it is quite important to make sure the correct Product Code(s) are entered in the submission in the submission because these are linked to other databases like Medical Device Listing or UDI.  If there were already indications cleared under the submission, this does not preclude a company from selling or marketing their product under a specific indications from which has been cleared.  Recommendation: document this internally how you are marketing/selling the device under the one indications; in the future it still gives the company the flexibility to market/sell under the other indications if needed.  If you wanted to limit the indication you could submit a new 510(k) application though this would be a lot of energy, time, and money which may not be needed.

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

Original Message:
Sent: 02-Aug-2022 11:50
From: Shikha Malik
Subject: product code in FDA database

Hello all,

I have a question related to updating the product code in FDA database for a 510(k) device. The device was initially cleared for three specific indications and the firm has decided to market the device for only one of those indications. I understand that this is not required a new 510(k) submission, however, I would like to understand the process of updating the product code in the 510(k) database due to this indication update/change.

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------

I beg to differ in regard to the Richard's statement "The US FDA's 510(k) database is "written in stone" meaning there are not updates, changes, or amendments which can be made to the database once a product has been cleared. " I am aware of at least one instance (since I was personally involved) where FDA had notified manufacturers of cleared devices that their product code is being modified to a new product code. The reason was to provide clarity in regard to how some of devices (cleared under the original product code) were intended to be used.  

In my opinion if the cleared product is not being (physically/functionally) modified to only comply with one of the 3 indications then is the IFU being modified to highlight how to use the device, or the contraindications being changed, or new warnings added to highlight how the device should be used.  If so, then the IFU provided (to the FDA) while clearing the device might have been quite broad and you may need to review the need for a special 510(k) (at a minimum).



------------------------------
Hrishikesh Gadagkar
Monroeville PA
United States
------------------------------

Original Message:
Sent: 03-Aug-2022 02:36
From: Richard Vincins
Subject: product code in FDA database

Good day Shikha,

The US FDA's 510(k) database is "written in stone" meaning there are not updates, changes, or amendments which can be made to the database once a product has been cleared.  This is why it is quite important to make sure the correct Product Code(s) are entered in the submission in the submission because these are linked to other databases like Medical Device Listing or UDI.  If there were already indications cleared under the submission, this does not preclude a company from selling or marketing their product under a specific indications from which has been cleared.  Recommendation: document this internally how you are marketing/selling the device under the one indications; in the future it still gives the company the flexibility to market/sell under the other indications if needed.  If you wanted to limit the indication you could submit a new 510(k) application though this would be a lot of energy, time, and money which may not be needed.

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

Original Message:
Sent: 02-Aug-2022 11:50
From: Shikha Malik
Subject: product code in FDA database

Hello all,

I have a question related to updating the product code in FDA database for a 510(k) device. The device was initially cleared for three specific indications and the firm has decided to market the device for only one of those indications. I understand that this is not required a new 510(k) submission, however, I would like to understand the process of updating the product code in the 510(k) database due to this indication update/change.

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------

Original Message:
Sent: 8/3/2022 8:09:00 AM
From: Hrishikesh Gadagkar
Subject: RE: product code in FDA database

I beg to differ in regard to the Richard's statement "The US FDA's 510(k) database is "written in stone" meaning there are not updates, changes, or amendments which can be made to the database once a product has been cleared. " I am aware of at least one instance (since I was personally involved) where FDA had notified manufacturers of cleared devices that their product code is being modified to a new product code. The reason was to provide clarity in regard to how some of devices (cleared under the original product code) were intended to be used.  

In my opinion if the cleared product is not being (physically/functionally) modified to only comply with one of the 3 indications then is the IFU being modified to highlight how to use the device, or the contraindications being changed, or new warnings added to highlight how the device should be used.  If so, then the IFU provided (to the FDA) while clearing the device might have been quite broad and you may need to review the need for a special 510(k) (at a minimum).



------------------------------
Hrishikesh Gadagkar
Monroeville PA
United States
------------------------------

Original Message:
Sent: 03-Aug-2022 02:36
From: Richard Vincins
Subject: product code in FDA database

Good day Shikha,

The US FDA's 510(k) database is "written in stone" meaning there are not updates, changes, or amendments which can be made to the database once a product has been cleared.  This is why it is quite important to make sure the correct Product Code(s) are entered in the submission in the submission because these are linked to other databases like Medical Device Listing or UDI.  If there were already indications cleared under the submission, this does not preclude a company from selling or marketing their product under a specific indications from which has been cleared.  Recommendation: document this internally how you are marketing/selling the device under the one indications; in the future it still gives the company the flexibility to market/sell under the other indications if needed.  If you wanted to limit the indication you could submit a new 510(k) application though this would be a lot of energy, time, and money which may not be needed.

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

Original Message:
Sent: 02-Aug-2022 11:50
From: Shikha Malik
Subject: product code in FDA database

Hello all,

I have a question related to updating the product code in FDA database for a 510(k) device. The device was initially cleared for three specific indications and the firm has decided to market the device for only one of those indications. I understand that this is not required a new 510(k) submission, however, I would like to understand the process of updating the product code in the 510(k) database due to this indication update/change.

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------

Yes. I mean the submitter of the 510(k) can not ask the FDA to retrospectively go and ask for something to be changed on a cleared 510(k) device which is in the database.  During the application process this is why the brand name, device description, and overall information in the 510(k) Summary is viewed carefully, because this does not change.

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

Original Message:
Sent: 03-Aug-2022 08:58
From: Ted Heise
Subject: product code in FDA database

 

 

 

I agree insofar as CDRH from time to time changing the assigned pro codes.  I've seen this too, and I expect anyone who's been in regulatory work for a meaningful amount of time will have as well.  I can't speak for Richard, but my assumption was "written in stone" reflected the virtual absence of ability for the 510(k) holder to make any changes.

 

Best regards,

 

Ted

 

--

Theodore (Ted) Heise, PHD, RAC

Vice President Regulatory and Clinical Services

 

MED Institute Inc.

1330 Win Hentschel Blvd.

West Lafayette, IN  47906-4149 USA

765.463.1633 ext. 4444

http://medinstitute.com

theise@medinstitute.com

 

 

 

Original Message:
Sent: 8/3/2022 8:09:00 AM
From: Hrishikesh Gadagkar
Subject: RE: product code in FDA database

I beg to differ in regard to the Richard's statement "The US FDA's 510(k) database is "written in stone" meaning there are not updates, changes, or amendments which can be made to the database once a product has been cleared. " I am aware of at least one instance (since I was personally involved) where FDA had notified manufacturers of cleared devices that their product code is being modified to a new product code. The reason was to provide clarity in regard to how some of devices (cleared under the original product code) were intended to be used.

In my opinion if the cleared product is not being (physically/functionally) modified to only comply with one of the 3 indications then is the IFU being modified to highlight how to use the device, or the contraindications being changed, or new warnings added to highlight how the device should be used.  If so, then the IFU provided (to the FDA) while clearing the device might have been quite broad and you may need to review the need for a special 510(k) (at a minimum).



------------------------------
Hrishikesh Gadagkar
Monroeville PA
United States

Original Message:
Sent: 03-Aug-2022 02:36
From: Richard Vincins
Subject: product code in FDA database

Good day Shikha,

The US FDA's 510(k) database is "written in stone" meaning there are not updates, changes, or amendments which can be made to the database once a product has been cleared.  This is why it is quite important to make sure the correct Product Code(s) are entered in the submission in the submission because these are linked to other databases like Medical Device Listing or UDI.  If there were already indications cleared under the submission, this does not preclude a company from selling or marketing their product under a specific indications from which has been cleared.  Recommendation: document this internally how you are marketing/selling the device under the one indications; in the future it still gives the company the flexibility to market/sell under the other indications if needed.  If you wanted to limit the indication you could submit a new 510(k) application though this would be a lot of energy, time, and money which may not be needed.

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

Original Message:
Sent: 02-Aug-2022 11:50
From: Shikha Malik
Subject: product code in FDA database

Hello all,

I have a question related to updating the product code in FDA database for a 510(k) device. The device was initially cleared for three specific indications and the firm has decided to market the device for only one of those indications. I understand that this is not required a new 510(k) submission, however, I would like to understand the process of updating the product code in the 510(k) database due to this indication update/change.

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------

I think this first begs the question how many product codes are associated with the 510k?  While occasionally there are two, in most cases there is just one.  Why is the original product code no longer appropriate, especially if you are narrowing indications within the intended use associated with the regulation?

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
------------------------------

Original Message:
Sent: 02-Aug-2022 11:50
From: Shikha Malik
Subject: product code in FDA database

Hello all,

I have a question related to updating the product code in FDA database for a 510(k) device. The device was initially cleared for three specific indications and the firm has decided to market the device for only one of those indications. I understand that this is not required a new 510(k) submission, however, I would like to understand the process of updating the product code in the 510(k) database due to this indication update/change.

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------

Multiple codes are not uncommon. There are some products that will even have a dozen codes, in particular, cardiac monitoring equipment.

FDA will occasionally change the code assignment for the already cleared product, for example when they create a new code that better fits the device indication or technology. This often creates a mismatch in what's in the database and the code that is listed in the 510(k) summary. 

I'm not aware of FDA changing information in the submission retrospectively. I even had a situation where I was notified by the agency several weeks after receiving the clearance that they will publish a De Novo summary (written by the FDA),  and asked if anything needs to be redacted. I responded that there is some information that should be corrected, because there were a few completely factual statements introduced by the FDA reviewer, and they wouldn't even allow that.

For all practical considerations, the product code itself does not dictate how the device is marketed, especially if the actual use is more narrow. The clearance itself does not compel the company to market the device at all in the first place.

------------------------------
Michael Zagorski RAC
Director of Regulatory Affairs
Pittsburgh PA
------------------------------

Original Message:
Sent: 03-Aug-2022 16:43
From: Michelle Lott
Subject: product code in FDA database

I think this first begs the question how many product codes are associated with the 510k?  While occasionally there are two, in most cases there is just one.  Why is the original product code no longer appropriate, especially if you are narrowing indications within the intended use associated with the regulation?

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com

Original Message:
Sent: 02-Aug-2022 11:50
From: Shikha Malik
Subject: product code in FDA database

Hello all,

I have a question related to updating the product code in FDA database for a 510(k) device. The device was initially cleared for three specific indications and the firm has decided to market the device for only one of those indications. I understand that this is not required a new 510(k) submission, however, I would like to understand the process of updating the product code in the 510(k) database due to this indication update/change.

Thanks!

------------------------------
Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
------------------------------