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Class 3 Device - Change of supplier of material

D

DH1981

Starting to get Involved
#1
#1
What sort of notification is requried for change in to a material supplier?
If we bring the manufacturing of that particular component in-house and the formulation and release specs are exactly the same does this consititute a significant change?
The only difference will be the part number. Is an update to the License required?
Thank you.
 
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D

DH1981

Starting to get Involved
#2
#2
What sort of notification is requried for change in to a material supplier?
If we bring the manufacturing of that particular component in-house and the formulation and release specs are exactly the same does this consititute a significant change?
The only difference will be the part number. Is and notification to FDA requried?
Thank you.
 
D

DH1981

Starting to get Involved
#4
#4
What sort of notification is requried for change in to a material supplier?
If we bring the manufacturing of that particular component in-house and the formulation and release specs are exactly the same does this consititute a significant change?
The only difference will be the part number. Is and notification to FDA requried?
Thank you.
 
William55401

William55401

Quite Involved in Discussions
#5
#5
Please share more. What is the device? What is the intended use? What is the component's role (with the change in material or material processing from buy to make) in the device?
 
R

RA Guy

Involved In Discussions
#7
#7
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