Sub-supplier change from manual to automated process - same specs - Report to FDA?

JB0424

Starting to get Involved
#1
Hello!

I have a differing opinion from my colleagues, so I would like to get other's opinions on the scenario below.

I received a change notice that is adding equipment at a sub-supplier to expand manufacturing capacity. The new equipment will change a part of the process from manual to automated.

We do not hold the relationship with this component supplier. Rather, our contract manufacturer maintains this relationship (it's the supplier of the contract manufacturer).
My question is do we need to report this change to FDA? The component specifications remain the same. Nothing is changing from how our device is manufactured at the contract manufacturer.

Thoughts?
 
Elsmar Forum Sponsor

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
What Shininov said above me. The FDA is concerned with changes or verification methods that differ from what was used in your original submission. This is an excerpt from our form.

Guidance Ref. No.
Question
Answer
Rationale
MAIN FLOWCHART
WHEN TO FILE A 510(K) AFTER CHANGE TO A LEGALLY MARKETED DEVICE

1
Change made with intent to significantly improve the safety or effectiveness of the device?
Yes -New 510K / No – See Question 2
??
Change is not to improve the safety or effectiveness of the device.
2
Labeling change?
Yes -See Chart A / No – See Question 3
??
No changes to product labels
3
Technology, engineering or performance change?
Yes -See Chart B / No – See Question 3
??
No changes to technology, engineering or performance
4
Materials change?
Yes -See Chart C / No – Documentation
??​
 
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