Sterilization Site Move - Dec 2018 FDA Guidance Document

Silvertabb

Involved In Discussions
#1
Hello
If we (the manufacturer) have to qualify a new sterilizer to sterilize our products, to whom the requirements listed in 9-13 in Section B of the FDA guidance titled "Manufacturing Site Change Supplements: Contens and Submission; dated Dec 2018" apply- contract sterilizer or the manufacturer?
I appreciate your response.
 
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shimonv

Trusted Information Resource
#2
Hi Silvertabb,
I am no expert with PMAs, but the guidance says: "[...] a PMA holder must submit a PMA supplement when it “use a different facility or establishment to manufacture, process, or package the device,” and the change affects the device’s safety or effectiveness.".

It seems to me that this is on the PMA holder (i.e. manufacturer) to provide all the necessary information; perhaps there is a way for the contract steriliser to send supporting information separately but the PMA holder bears the overall responsibility.
 
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