Interpretation of significant change - material change

kate · Jul 16, 2019

Hi!
I have a couple of questions about Flowchart F (materials change in non-IVDD device) of Health Canada Guidance for the Interpretation of Significant Change of a Medical Device.

1) is the term "contact" used in the flowchart referring to both direct and indirect?
2) if the device not intended to be absorbed by the body or to remain in the body for at least 30 consecutive days, but the altered material is in contact with body tissues or fluid, change to the "specification" has to be considered. What is your interpretation of this "specification"? Is it specification of the material or of the device or of the part?
If there is a change to the material, in which instances there will be no change to the specification?

Thank you for your help!!

shimonv · Jul 16, 2019

Hi Kate,
Since regulatory is all about risk based approach it would be helpful to know what the device is and what is the intended change.

1. Since no interpretation is offerer in this guidance, I would take the term "Contact" as referring to direct contact. However, if indirect contact is likely to occur (based on risk management or usability study) and it is significant from risk based approach, I will regard "contact" as referring to both direct and indirect contact.
2. You need to ask the question "have the specification changed?" for every material that is effected by the change.
3. I would say in most cases a change in material means a change in specification. In cases where the material composition is insignificant (for example, washers for screws) and therefore not specified in the drawings - you could say that specification has not changed.

Shimon

kate · Jul 16, 2019

shimonv said:
Hi Kate,
Since regulatory is all about risk based approach it would be helpful to know what the device is and what is the intended change.

1. Since no interpretation is offerer in this guidance, I would take the term "Contact" as referring to direct contact. However, if indirect contact is likely to occur (based on risk management or usability study) and it is significant from risk based approach, I will regard "contact" as referring to both direct and indirect contact.
2. You need to ask the question "have the specification changed?" for every material that is effected by the change.
3. I would say in most cases a change in material means a change in specification. In cases where the material composition is insignificant (for example, washers for screws) and therefore not specified in the drawings - you could say that specification has not changed.

Shimon

Thanks for your input. It would be material change from the current material to nitinol. The device in question is a catheter with limited exposure (<24hours).

shimonv · Jul 17, 2019

So I think you have your answer..

Interpretation of significant change - material change

kate

Registered

shimonv

kate

Registered

shimonv

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