Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,
I need help in understanding Significant and non significant design change processes.
Do all minor and insignificant changes have to follow design control procedures?

1) How does one determine what a significant change is and what documents to produce ? ( Design input, risk assessments , human factors, V and V etc )
2) If its a minor insignificant change do we still need to define and follow ( Design input, risk assessments , human factors, V and V etc ) or just an engineering change order will suffice?

Is there any links or articles that I can look up to understand how should a QMS address these issues and at each step what are the document requirements?

Thanks

Hello,

There are a couple guidance documents out there you can use giving some ideas on significant changes.  However, what I would strongly recommend in your design control change process, engineering change process, product change process you have a methodology and or definitions for a significant change to your device.  A significant change from one device can be different from other, also based on class the regulatory acceptance might be less or greater.

FDA Guidance on when to submit a 510(k): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device
The relatively new MDCG guidance 2020-3 in relation to Article 120: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
The NBOG document 2014-3 for significant change: https://www.nbog.eu/nbog-documents/

There may also be some articles out there you can research.
To answer your questions:
1. The answer is quite involved, but your change control system should address what needs to be done based on the type of change andd performing a change impact assessment.  From my perspective any change to the product is a design change.  How much you do depends on whether it can be managed solely through a single engineering change order (ECO)/change order (CO) or maybe a new design project needs to be done.  As an example, changing a component could be a single ECO/CO with maybe a single verification test.  Another example is a power supply and PCB board need to be changed.  This may cause a "mini" design control process to ensue.  There could be multiple ECO/CO with this change and multiple verification and validation tests.  Your quality system needs to be able to address the type of changes being made.  When you follow design control procedures and the "standard" change control procedure, need to make that determination based on your device and classification.
2. Maybe.  Again it depends on your change, how you define significant change, your device, etc.  The example above gives a short introduction on how you can look at this from a change perspective.  Typically a "minor" change would be handled through the ECO/CO system only - but depending on your design control process, additional documentation or work may need to be performed.  Personally, in the change control process the question should be asked, 'Do we need to go back into Design Controls? Or can this be managed solely by this change order?'  Then provide the rationale and justification.

Good luck !

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

Original Message:
Sent: 14-Apr-2020 21:50
From: Anonymous Member
Subject: Incremental Design Changes

This message was posted by a user wishing to remain anonymous

Hi,
I need help in understanding Significant and non significant design change processes.
Do all minor and insignificant changes have to follow design control procedures?

1) How does one determine what a significant change is and what documents to produce ? ( Design input, risk assessments , human factors, V and V etc )
2) If its a minor insignificant change do we still need to define and follow ( Design input, risk assessments , human factors, V and V etc ) or just an engineering change order will suffice?

Is there any links or articles that I can look up to understand how should a QMS address these issues and at each step what are the document requirements?

Thanks

Thank you for this reply Richard, i think this is a great explanation - also thanks for the heads up on the MDCG guidance document, this has personally helped me very much.

------------------------------
Keri Wilkie
Renfrew
United Kingdom
------------------------------

Original Message:
Sent: 16-Apr-2020 04:28
From: Richard Vincins
Subject: Incremental Design Changes

Hello,

There are a couple guidance documents out there you can use giving some ideas on significant changes.  However, what I would strongly recommend in your design control change process, engineering change process, product change process you have a methodology and or definitions for a significant change to your device.  A significant change from one device can be different from other, also based on class the regulatory acceptance might be less or greater.

FDA Guidance on when to submit a 510(k): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device
The relatively new MDCG guidance 2020-3 in relation to Article 120: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
The NBOG document 2014-3 for significant change: https://www.nbog.eu/nbog-documents/

There may also be some articles out there you can research.
To answer your questions:
1. The answer is quite involved, but your change control system should address what needs to be done based on the type of change andd performing a change impact assessment.  From my perspective any change to the product is a design change.  How much you do depends on whether it can be managed solely through a single engineering change order (ECO)/change order (CO) or maybe a new design project needs to be done.  As an example, changing a component could be a single ECO/CO with maybe a single verification test.  Another example is a power supply and PCB board need to be changed.  This may cause a "mini" design control process to ensue.  There could be multiple ECO/CO with this change and multiple verification and validation tests.  Your quality system needs to be able to address the type of changes being made.  When you follow design control procedures and the "standard" change control procedure, need to make that determination based on your device and classification.
2. Maybe.  Again it depends on your change, how you define significant change, your device, etc.  The example above gives a short introduction on how you can look at this from a change perspective.  Typically a "minor" change would be handled through the ECO/CO system only - but depending on your design control process, additional documentation or work may need to be performed.  Personally, in the change control process the question should be asked, 'Do we need to go back into Design Controls? Or can this be managed solely by this change order?'  Then provide the rationale and justification.

Good luck !

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

Original Message:
Sent: 14-Apr-2020 21:50
From: Anonymous Member
Subject: Incremental Design Changes

This message was posted by a user wishing to remain anonymous

Hi,
I need help in understanding Significant and non significant design change processes.
Do all minor and insignificant changes have to follow design control procedures?

1) How does one determine what a significant change is and what documents to produce ? ( Design input, risk assessments , human factors, V and V etc )
2) If its a minor insignificant change do we still need to define and follow ( Design input, risk assessments , human factors, V and V etc ) or just an engineering change order will suffice?

Is there any links or articles that I can look up to understand how should a QMS address these issues and at each step what are the document requirements?

Thanks

This message was posted by a user wishing to remain anonymous

Thank everyone for this valuable support.
@ Richard, Keri, William, Edwin and Dan.

Cant thank you all enough :)​
Original Message:
Sent: 16-Apr-2020 04:28
From: Richard Vincins
Subject: Incremental Design Changes

Hello,

There are a couple guidance documents out there you can use giving some ideas on significant changes.  However, what I would strongly recommend in your design control change process, engineering change process, product change process you have a methodology and or definitions for a significant change to your device.  A significant change from one device can be different from other, also based on class the regulatory acceptance might be less or greater.

FDA Guidance on when to submit a 510(k): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device
The relatively new MDCG guidance 2020-3 in relation to Article 120: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
The NBOG document 2014-3 for significant change: https://www.nbog.eu/nbog-documents/

There may also be some articles out there you can research.
To answer your questions:
1. The answer is quite involved, but your change control system should address what needs to be done based on the type of change andd performing a change impact assessment.  From my perspective any change to the product is a design change.  How much you do depends on whether it can be managed solely through a single engineering change order (ECO)/change order (CO) or maybe a new design project needs to be done.  As an example, changing a component could be a single ECO/CO with maybe a single verification test.  Another example is a power supply and PCB board need to be changed.  This may cause a "mini" design control process to ensue.  There could be multiple ECO/CO with this change and multiple verification and validation tests.  Your quality system needs to be able to address the type of changes being made.  When you follow design control procedures and the "standard" change control procedure, need to make that determination based on your device and classification.
2. Maybe.  Again it depends on your change, how you define significant change, your device, etc.  The example above gives a short introduction on how you can look at this from a change perspective.  Typically a "minor" change would be handled through the ECO/CO system only - but depending on your design control process, additional documentation or work may need to be performed.  Personally, in the change control process the question should be asked, 'Do we need to go back into Design Controls? Or can this be managed solely by this change order?'  Then provide the rationale and justification.

Good luck !

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

Original Message:
Sent: 14-Apr-2020 21:50
From: Anonymous Member
Subject: Incremental Design Changes

This message was posted by a user wishing to remain anonymous

Hi,
I need help in understanding Significant and non significant design change processes.
Do all minor and insignificant changes have to follow design control procedures?

1) How does one determine what a significant change is and what documents to produce ? ( Design input, risk assessments , human factors, V and V etc )
2) If its a minor insignificant change do we still need to define and follow ( Design input, risk assessments , human factors, V and V etc ) or just an engineering change order will suffice?

Is there any links or articles that I can look up to understand how should a QMS address these issues and at each step what are the document requirements?

Thanks

Anonymous,

IMO, if your design is in design control then yes all changes must follow the design control procedures approved through your management of change procedure.

1) IMO, determination of significance is a technical question that is likely answered through the approval of your ECR/ECO, again reviewed and approved through your management of change procedure.  Likely, you will accomplish many of the things you mention.  Also, consider FDA Guidance For Industry: when to submit a new 510k for an existing device.

2) IMO, whether a change is minor or not, it must follow design control (if in design control) and management of change procedures.  

Respectfully,

------------------------------
William Coulston PMP, MS, RAC
Quality & Regulatory Manager
San Antonio TX
United States
------------------------------

Original Message:
Sent: 14-Apr-2020 21:50
From: Anonymous Member
Subject: Incremental Design Changes

This message was posted by a user wishing to remain anonymous

Hi,
I need help in understanding Significant and non significant design change processes.
Do all minor and insignificant changes have to follow design control procedures?

1) How does one determine what a significant change is and what documents to produce ? ( Design input, risk assessments , human factors, V and V etc )
2) If its a minor insignificant change do we still need to define and follow ( Design input, risk assessments , human factors, V and V etc ) or just an engineering change order will suffice?

Is there any links or articles that I can look up to understand how should a QMS address these issues and at each step what are the document requirements?

Thanks

Yes, all design changes must be handled Under the design control process, but also changes to the manufacturing process (design transfer 21 CFR 820.30(h)) should be considered under design change. Yesterday I participated in a training session with an individual from CDRH compliance that mentioned that we should evaluate small "insignificant" incremental changes to determine if they, over time, have made significant change to the original device, which may require a new submission.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 16-Apr-2020 09:28
From: William Coulston
Subject: Incremental Design Changes

Anonymous,

IMO, if your design is in design control then yes all changes must follow the design control procedures approved through your management of change procedure.

1) IMO, determination of significance is a technical question that is likely answered through the approval of your ECR/ECO, again reviewed and approved through your management of change procedure.  Likely, you will accomplish many of the things you mention.  Also, consider FDA Guidance For Industry: when to submit a new 510k for an existing device.

2) IMO, whether a change is minor or not, it must follow design control (if in design control) and management of change procedures.

Respectfully,

------------------------------
William Coulston PMP, MS, RAC
Quality & Regulatory Manager
San Antonio TX
United States

Original Message:
Sent: 14-Apr-2020 21:50
From: Anonymous Member
Subject: Incremental Design Changes

This message was posted by a user wishing to remain anonymous

Hi,
I need help in understanding Significant and non significant design change processes.
Do all minor and insignificant changes have to follow design control procedures?

1) How does one determine what a significant change is and what documents to produce ? ( Design input, risk assessments , human factors, V and V etc )
2) If its a minor insignificant change do we still need to define and follow ( Design input, risk assessments , human factors, V and V etc ) or just an engineering change order will suffice?

Is there any links or articles that I can look up to understand how should a QMS address these issues and at each step what are the document requirements?

Thanks

There are two aspects to consider – the internal design change process and the external regulatory requirements.

For the internal process, do not classify design changes as significant or not. Each design change must follow the design change process. You need to careful about the identification of a design change. For example, FDA's QSIT suggests that many 820.70(b) production and process changes are also 820.30(i) design changes. QSIT says that the organizational structure doesn't matter, but following 820.30(i) does. Manufacturing engineering, for example, could implement the design change; design engineering is not required.

When you work on a design change, consider what has changed. You may not need to perform some activities. For example, if the design change doesn't affect patient or user needs, then design validation is not warranted. Document your rationale and include it in the DHF.

The issue of significance is import for the regulatory aspects. For example, if you have a design change for a 510(k) device then you must evaluate it to determine the need for a new 510(k). Similarly, the EU-MDR Annex IX requires an evaluation of design changes to determine the need to notify the NB.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 14-Apr-2020 21:50
From: Anonymous Member
Subject: Incremental Design Changes

This message was posted by a user wishing to remain anonymous

Hi,
I need help in understanding Significant and non significant design change processes.
Do all minor and insignificant changes have to follow design control procedures?

1) How does one determine what a significant change is and what documents to produce ? ( Design input, risk assessments , human factors, V and V etc )
2) If its a minor insignificant change do we still need to define and follow ( Design input, risk assessments , human factors, V and V etc ) or just an engineering change order will suffice?

Is there any links or articles that I can look up to understand how should a QMS address these issues and at each step what are the document requirements?

Thanks