Rob Packard It's an unusual situation. It sounds like you are the manufacturer, but the product is generic so you might not be the specifications developer. Typically sterilization will only be performed to the manufacturer's instructions. If you package, label and sterilize--then your're the manufacturer and should list as such. If it's class 1 it's easy, if this is for a class II you might need a 510k. You can contact me directly if you want answers to your specific situation.

Dr. Patrick Druggan If the product needs to be sterile to use in the application, it would imply that the critical step is sterilisation and you are the manufacturer

Julie Omohundro I will assume you are referring to listing the device with FDA.

Yes, I think you are the manufacturer. That's because I think sterilizing, packaging, and labeling are part of the manufacturing process, and that any company that performs these activities (or contracts another company to perform them on its behalf) is a manufacturer.

I don't think you are buying your device in bulk, off the shelf, non-sterile. I think you are buying another company's device in bulk, off the shelf, non-sterile, and using it to manufacture your device. Whether the other company's device is a medical device in its own right and/or could be used for the same intended use as your device, even if it were sterilized or in your packaging or with your labeling, is another whole can of worms.

Mark Proulx, CQA, cSSBB Trey Thorsen, RAC, ASQ CQA I can tell you that you would be no different than any other assembler company that purchases each other their components from sister divisions. The "sister" divisions are treated by the FDA as suppliers to be qualified as would any other 3rd party and you, since you are performing processing operations before the device can be sold, would be considered the manufacturer. You will need to have all the design documents and specifications, qualifications of the manufacturer you buy your product from, incoming inspection criteria, and final acceptance testing performed as if you had made the product yourself. This is akin to your contracting another manufacturer to make this specifically for you (which, realistically, you are...) and you complete manufacturing operations. If you did no manipulation and only repackaged bulk into smaller containers for resale, then you would be a repackager. In this case, you are performing critical manufacturing operations.

Anastasia Tas no matter which part of manufacturing process you do
if device is under your name on the market, you are the manufacturer.

Zoltan Deri I think that question is linked with two aspects of risks

1/ If the device specification including option for sterilisation, you should follow exactly that process.... Quality agreement with original M
Safety reports to original M - original classification can be applied within 30 Day Notification

2/ If the device specification not including option for sterilisation (New pre marketing approval - PMA required 135 Day)
The 1st step to get license from original M (as supplier) for this product, informing them you intend to apply for new class (sterile product vs non sterile) otherwise you should have missed a significant part of supporting documentation for this device. Your application with this supporting documentation including the applied sterilisation procedure (My concern regarding the impact of sterilisation on the stability, integrity, safety of the original device) to FDA for new class.
(Safety database owner)

Buying off the shelf unfinished device is like buying a component. I think you have to be labelled as the manufacturer. Plus you will have to take responsibility of conformity of the original manufacturer of the unsterilized device

Gheorghe Ion Mija There is not mandatory that you make the sterilisation. You will be the manufacturer of the product and if you sign a contract with a sterilization facility and that facility pass and hold certificates for quality, there it will not be any problem. There are big brands that use this kind of outsourceing for sterilization and are specified in their certificates.