Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear all, 
we have submitted our 510k to FDA few months ago and, based on the feedback provided in the AI letter, I believe we are close to clearance.
Our R&D team would like to implement several changes to the device that was in the scope of the submission and we are doing for the first time the exercise of reviewing each change (+ the cumulative change) based on the flowcharts provided in the two guidances of the FDA (general + software), hoping we can manage such changes only by QMS. As this is the first time we do this exercise, we aren't sure about the level of detail that it is expected by FDA. We also have some doubts on specific changes that in Europe (under MDR) were assessed as non-substantial, but FDA may evaluate differently. Some questions for you:

1. does anybody has an example of change assessment that could share with me? I am not talking of the general template with the questions to be asked (taken by the guidances and flowcharts), nor the template provided in the guidance, but an example of how a good assessment should be done. 
2. One of the changes that creates some concerns is our Li-ion battery. 
   • 510k  version: 39 cells (13S3P), fitted in a rectangular-shaped casing. Casing is made of flame-retardant material. Plug system is based on an external metallic hook.
   • Proposed change: 26 cells (13S2P), fitted in a pill-shaped casing. Material casing changes but it is still flame-retardant. Plug system uses a sliding round button. Battery level-of-charge indicator is shown in the new version. The charger locking system is adapted to the new batteries. Charging time is reduced. Same tests (62133, 60601-1, 60601-1-2) done for the first battery are repeated, risks remain the same. 
   • Our first assessment is that there is no change of the control mechanism nor operating principle nor energy type, biocomp is not affected (as the part should not be touched), test are exactly the same --> Non-substantial. 
   • Does any of you have experience with a similar change and can share his/her experience and thoughts?
3. In the case of non-substantial assessment of all the changes:
   • can you confirm that the note to file should only be recorded in our QMS and not submitted to the FDA? This is my understanding but we were challenged by a consultant stating that we are supposed to submit a 510k amendment to "notify" FDA. To the best of my knowledge there is no such a thing as a 510k amendment for changes.
   • Do you recommend to update the 510k and keep it in our records in case of an inspection or a document with the changes' assessment and a discussion on why the device is still substantial equivalent is sufficient?
   • is there a way to communicate with FDA and check that they agree that changes are not substantial? How? Through a presub or simply by reaching out to the original lead reviewer?

Thanks in advance for any guidance you can provide.
Best

Hello Anon,

Your questions and situation is quite broad including many different considerations, probably the main one being the type of device and intended use.  It might be beneficial for you to seek expert advice because thoughts and approach to significant changes can be a bit subjective - assuming also you have reviewed in detail the FDA Guidance for determination of changes.  In addition, because you have a premarket notification 510(k) still in process, not yet cleared, again it might be beneficial to discuss with an expert best approach on change implementation considering the product is not yet cleared.  Sorry to not answer specifically, but many of the questions you are asking are not just a "do this" response and has other implications which need to be considered.​

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

Original Message:
Sent: 07-Sep-2022 04:57
From: Anonymous Member
Subject: Implement design changes after 510k clearance

This message was posted by a user wishing to remain anonymous

Dear all,
we have submitted our 510k to FDA few months ago and, based on the feedback provided in the AI letter, I believe we are close to clearance.
Our R&D team would like to implement several changes to the device that was in the scope of the submission and we are doing for the first time the exercise of reviewing each change (+ the cumulative change) based on the flowcharts provided in the two guidances of the FDA (general + software), hoping we can manage such changes only by QMS. As this is the first time we do this exercise, we aren't sure about the level of detail that it is expected by FDA. We also have some doubts on specific changes that in Europe (under MDR) were assessed as non-substantial, but FDA may evaluate differently. Some questions for you:

1. does anybody has an example of change assessment that could share with me? I am not talking of the general template with the questions to be asked (taken by the guidances and flowcharts), nor the template provided in the guidance, but an example of how a good assessment should be done. 
2. One of the changes that creates some concerns is our Li-ion battery. 
   • 510k  version: 39 cells (13S3P), fitted in a rectangular-shaped casing. Casing is made of flame-retardant material. Plug system is based on an external metallic hook.
   • Proposed change: 26 cells (13S2P), fitted in a pill-shaped casing. Material casing changes but it is still flame-retardant. Plug system uses a sliding round button. Battery level-of-charge indicator is shown in the new version. The charger locking system is adapted to the new batteries. Charging time is reduced. Same tests (62133, 60601-1, 60601-1-2) done for the first battery are repeated, risks remain the same. 
   • Our first assessment is that there is no change of the control mechanism nor operating principle nor energy type, biocomp is not affected (as the part should not be touched), test are exactly the same --> Non-substantial. 
   • Does any of you have experience with a similar change and can share his/her experience and thoughts?
3. In the case of non-substantial assessment of all the changes:
   • can you confirm that the note to file should only be recorded in our QMS and not submitted to the FDA? This is my understanding but we were challenged by a consultant stating that we are supposed to submit a 510k amendment to "notify" FDA. To the best of my knowledge there is no such a thing as a 510k amendment for changes.
   • Do you recommend to update the 510k and keep it in our records in case of an inspection or a document with the changes' assessment and a discussion on why the device is still substantial equivalent is sufficient?
   • is there a way to communicate with FDA and check that they agree that changes are not substantial? How? Through a presub or simply by reaching out to the original lead reviewer?

Thanks in advance for any guidance you can provide.
Best

Which FDA Guidance have you reviewed ? See attachment.

Our full-text search SmartSearch identified these in the attachment when using the advance full test search  keywords below:
"(510* NEAR (chang* NEAR energy))"

ie -find FDA PDF Guidances on medical devices (CDRH)  where PDF contains the terms  '510'  next to  ( 'change' next to 'energy)

The 1st PDF on the attachment happens to include an example scenario where energy source is changed, yours apparently if I read it right does not change energy source type nor according to you does not change control mechanism nor operating principles as well.

You should review this  section below  contained in the 1st PDF search result  came up on 21 CFR 807 referenced:
" As stated in that guidance, the key issue in the interpretation of 21 CFR 807.81(a)(3) is that the phrase "could significantly affect the safety or effectiveness of the device" and the use of the adjectives "major" and "significant" sometimes lead FDA and device manufacturers to different interpretations"

So if your design change testing after the energy source changed  has been validated (shown objectively with testing and documentation)
seems to me no new 510K is required to be submitted. Key is what the re-testing showed after battery source changed.
As you must know PDF Guidance represent US FDA current thinking whereas 21 CFRs are legally binding statutes.

Ram Balani
Sign up free for SmartSearch access - https://tinyurl.com/cxapx5c6 

------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
------------------------------

Original Message:
Sent: 07-Sep-2022 04:57
From: Anonymous Member
Subject: Implement design changes after 510k clearance

This message was posted by a user wishing to remain anonymous

Dear all,
we have submitted our 510k to FDA few months ago and, based on the feedback provided in the AI letter, I believe we are close to clearance.
Our R&D team would like to implement several changes to the device that was in the scope of the submission and we are doing for the first time the exercise of reviewing each change (+ the cumulative change) based on the flowcharts provided in the two guidances of the FDA (general + software), hoping we can manage such changes only by QMS. As this is the first time we do this exercise, we aren't sure about the level of detail that it is expected by FDA. We also have some doubts on specific changes that in Europe (under MDR) were assessed as non-substantial, but FDA may evaluate differently. Some questions for you:

1. does anybody has an example of change assessment that could share with me? I am not talking of the general template with the questions to be asked (taken by the guidances and flowcharts), nor the template provided in the guidance, but an example of how a good assessment should be done. 
2. One of the changes that creates some concerns is our Li-ion battery. 
   • 510k  version: 39 cells (13S3P), fitted in a rectangular-shaped casing. Casing is made of flame-retardant material. Plug system is based on an external metallic hook.
   • Proposed change: 26 cells (13S2P), fitted in a pill-shaped casing. Material casing changes but it is still flame-retardant. Plug system uses a sliding round button. Battery level-of-charge indicator is shown in the new version. The charger locking system is adapted to the new batteries. Charging time is reduced. Same tests (62133, 60601-1, 60601-1-2) done for the first battery are repeated, risks remain the same. 
   • Our first assessment is that there is no change of the control mechanism nor operating principle nor energy type, biocomp is not affected (as the part should not be touched), test are exactly the same --> Non-substantial. 
   • Does any of you have experience with a similar change and can share his/her experience and thoughts?
3. In the case of non-substantial assessment of all the changes:
   • can you confirm that the note to file should only be recorded in our QMS and not submitted to the FDA? This is my understanding but we were challenged by a consultant stating that we are supposed to submit a 510k amendment to "notify" FDA. To the best of my knowledge there is no such a thing as a 510k amendment for changes.
   • Do you recommend to update the 510k and keep it in our records in case of an inspection or a document with the changes' assessment and a discussion on why the device is still substantial equivalent is sufficient?
   • is there a way to communicate with FDA and check that they agree that changes are not substantial? How? Through a presub or simply by reaching out to the original lead reviewer?

Thanks in advance for any guidance you can provide.
Best

Dear Anon

Agree that expert advice is helpful in a tricky situation.

You might be interested in reading the guidance "Types of Communication During the Review of Medical Device Submissions". It talks about amending a submission during the review process - for example, when it needs clarification or correction of deficiencies.

That is different from the process for evaluating changes after clearance. In that case you are correct that a letter to file goes into your own file and is not proactively submitted to FDA. You can read about such evaluations in the guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device".

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 08-Sep-2022 11:51
From: Ram Balani
Subject: Implement design changes after 510k clearance

Which FDA Guidance have you reviewed ? See attachment.

Our full-text search SmartSearch identified these in the attachment when using the advance full test search  keywords below:
"(510* NEAR (chang* NEAR energy))"

ie -find FDA PDF Guidances on medical devices (CDRH)  where PDF contains the terms  '510'  next to  ( 'change' next to 'energy)

The 1st PDF on the attachment happens to include an example scenario where energy source is changed, yours apparently if I read it right does not change energy source type nor according to you does not change control mechanism nor operating principles as well.

You should review this  section below  contained in the 1st PDF search result  came up on 21 CFR 807 referenced:
" As stated in that guidance, the key issue in the interpretation of 21 CFR 807.81(a)(3) is that the phrase "could significantly affect the safety or effectiveness of the device" and the use of the adjectives "major" and "significant" sometimes lead FDA and device manufacturers to different interpretations"

So if your design change testing after the energy source changed  has been validated (shown objectively with testing and documentation)
seems to me no new 510K is required to be submitted. Key is what the re-testing showed after battery source changed.
As you must know PDF Guidance represent US FDA current thinking whereas 21 CFRs are legally binding statutes.

Ram Balani
Sign up free for SmartSearch access - https://tinyurl.com/cxapx5c6 

------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)

Original Message:
Sent: 07-Sep-2022 04:57
From: Anonymous Member
Subject: Implement design changes after 510k clearance

This message was posted by a user wishing to remain anonymous

Dear all,
we have submitted our 510k to FDA few months ago and, based on the feedback provided in the AI letter, I believe we are close to clearance.
Our R&D team would like to implement several changes to the device that was in the scope of the submission and we are doing for the first time the exercise of reviewing each change (+ the cumulative change) based on the flowcharts provided in the two guidances of the FDA (general + software), hoping we can manage such changes only by QMS. As this is the first time we do this exercise, we aren't sure about the level of detail that it is expected by FDA. We also have some doubts on specific changes that in Europe (under MDR) were assessed as non-substantial, but FDA may evaluate differently. Some questions for you:

1. does anybody has an example of change assessment that could share with me? I am not talking of the general template with the questions to be asked (taken by the guidances and flowcharts), nor the template provided in the guidance, but an example of how a good assessment should be done. 
2. One of the changes that creates some concerns is our Li-ion battery. 
   • 510k  version: 39 cells (13S3P), fitted in a rectangular-shaped casing. Casing is made of flame-retardant material. Plug system is based on an external metallic hook.
   • Proposed change: 26 cells (13S2P), fitted in a pill-shaped casing. Material casing changes but it is still flame-retardant. Plug system uses a sliding round button. Battery level-of-charge indicator is shown in the new version. The charger locking system is adapted to the new batteries. Charging time is reduced. Same tests (62133, 60601-1, 60601-1-2) done for the first battery are repeated, risks remain the same. 
   • Our first assessment is that there is no change of the control mechanism nor operating principle nor energy type, biocomp is not affected (as the part should not be touched), test are exactly the same --> Non-substantial. 
   • Does any of you have experience with a similar change and can share his/her experience and thoughts?
3. In the case of non-substantial assessment of all the changes:
   • can you confirm that the note to file should only be recorded in our QMS and not submitted to the FDA? This is my understanding but we were challenged by a consultant stating that we are supposed to submit a 510k amendment to "notify" FDA. To the best of my knowledge there is no such a thing as a 510k amendment for changes.
   • Do you recommend to update the 510k and keep it in our records in case of an inspection or a document with the changes' assessment and a discussion on why the device is still substantial equivalent is sufficient?
   • is there a way to communicate with FDA and check that they agree that changes are not substantial? How? Through a presub or simply by reaching out to the original lead reviewer?

Thanks in advance for any guidance you can provide.
Best

This message was posted by a user wishing to remain anonymous

Thank you all. Do you have any suggestions about consultants with electromedical devices expertise (strong in SW, Electronic, Mechanics, Battery topics) that can help us on this specific topic of change assessment?
Also, do you update the 510k even in cases of simple note to file?
Thanks in advance.
Original Message:
Sent: 08-Sep-2022 12:24
From: Anne LeBlanc
Subject: Implement design changes after 510k clearance

Dear Anon

Agree that expert advice is helpful in a tricky situation.

You might be interested in reading the guidance "Types of Communication During the Review of Medical Device Submissions". It talks about amending a submission during the review process - for example, when it needs clarification or correction of deficiencies.

That is different from the process for evaluating changes after clearance. In that case you are correct that a letter to file goes into your own file and is not proactively submitted to FDA. You can read about such evaluations in the guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device".

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 08-Sep-2022 11:51
From: Ram Balani
Subject: Implement design changes after 510k clearance

Which FDA Guidance have you reviewed ? See attachment.

Our full-text search SmartSearch identified these in the attachment when using the advance full test search  keywords below:
"(510* NEAR (chang* NEAR energy))"

ie -find FDA PDF Guidances on medical devices (CDRH)  where PDF contains the terms  '510'  next to  ( 'change' next to 'energy)

The 1st PDF on the attachment happens to include an example scenario where energy source is changed, yours apparently if I read it right does not change energy source type nor according to you does not change control mechanism nor operating principles as well.

You should review this  section below  contained in the 1st PDF search result  came up on 21 CFR 807 referenced:
" As stated in that guidance, the key issue in the interpretation of 21 CFR 807.81(a)(3) is that the phrase "could significantly affect the safety or effectiveness of the device" and the use of the adjectives "major" and "significant" sometimes lead FDA and device manufacturers to different interpretations"

So if your design change testing after the energy source changed  has been validated (shown objectively with testing and documentation)
seems to me no new 510K is required to be submitted. Key is what the re-testing showed after battery source changed.
As you must know PDF Guidance represent US FDA current thinking whereas 21 CFRs are legally binding statutes.

Ram Balani
Sign up free for SmartSearch access - https://tinyurl.com/cxapx5c6 

------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)

Original Message:
Sent: 07-Sep-2022 04:57
From: Anonymous Member
Subject: Implement design changes after 510k clearance

This message was posted by a user wishing to remain anonymous

Dear all,
we have submitted our 510k to FDA few months ago and, based on the feedback provided in the AI letter, I believe we are close to clearance.
Our R&D team would like to implement several changes to the device that was in the scope of the submission and we are doing for the first time the exercise of reviewing each change (+ the cumulative change) based on the flowcharts provided in the two guidances of the FDA (general + software), hoping we can manage such changes only by QMS. As this is the first time we do this exercise, we aren't sure about the level of detail that it is expected by FDA. We also have some doubts on specific changes that in Europe (under MDR) were assessed as non-substantial, but FDA may evaluate differently. Some questions for you:

1. does anybody has an example of change assessment that could share with me? I am not talking of the general template with the questions to be asked (taken by the guidances and flowcharts), nor the template provided in the guidance, but an example of how a good assessment should be done. 
2. One of the changes that creates some concerns is our Li-ion battery. 
   • 510k  version: 39 cells (13S3P), fitted in a rectangular-shaped casing. Casing is made of flame-retardant material. Plug system is based on an external metallic hook.
   • Proposed change: 26 cells (13S2P), fitted in a pill-shaped casing. Material casing changes but it is still flame-retardant. Plug system uses a sliding round button. Battery level-of-charge indicator is shown in the new version. The charger locking system is adapted to the new batteries. Charging time is reduced. Same tests (62133, 60601-1, 60601-1-2) done for the first battery are repeated, risks remain the same. 
   • Our first assessment is that there is no change of the control mechanism nor operating principle nor energy type, biocomp is not affected (as the part should not be touched), test are exactly the same --> Non-substantial. 
   • Does any of you have experience with a similar change and can share his/her experience and thoughts?
3. In the case of non-substantial assessment of all the changes:
   • can you confirm that the note to file should only be recorded in our QMS and not submitted to the FDA? This is my understanding but we were challenged by a consultant stating that we are supposed to submit a 510k amendment to "notify" FDA. To the best of my knowledge there is no such a thing as a 510k amendment for changes.
   • Do you recommend to update the 510k and keep it in our records in case of an inspection or a document with the changes' assessment and a discussion on why the device is still substantial equivalent is sufficient?
   • is there a way to communicate with FDA and check that they agree that changes are not substantial? How? Through a presub or simply by reaching out to the original lead reviewer?

Thanks in advance for any guidance you can provide.
Best