Information required about changing an off shelf part




We are changing an off shelf part with a new part of the same kind, its like replacing one T- joint with a new T- joint which is like one of a small piece of a puzzle. I would like to know whether it comes under minor or major design change and do we need to do the bio-compatibility and Age testing for the entire product.

Kindly help me with this problem.

Jim Wynne

Welcome to the Cove. :bigwave: You posted this same question in five different forums, which will cause confusion. I deleted the other four and left this one in what appears to be the correct forum.

Mark Meer

Trusted Information Resource
Hi Eyeclicker.

The unsatisfying answer is: it depends.

Ultimately the assessment is up to you, and will depend on the nature of the product, and the role the replaced part plays.

Does replacing the part potentially invalidate previous biocompatibility testing? If so, then yes, you will have to revisit biocompatibility (which may or may not involve retesting).

Check out this FDA Guidance, and Health Canada Interpretation for some guidance on assessing the significance of the change.
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