Definition of repackager v. manufacturer


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Hi all,

We are having an internal discussion regarding the registration with the FDA of a potential medical device. We are looking at ways to source this device and the different methods of sourcing impact how we register with the FDA and label the product.

In this case, we have the option to:
(1) manufacture the critical component through a contract manufacturer to an extent that no major parts are complete or usable and then assemble and package everything in our facility,​
(2) manufacture the critical component with a contract manufacturer to a degree that it's complete except disassembled and unpackaged (this level of assembly by the finished user is expected. so we put all the parts together and package/label in our facility, but everything would be provided by the contract manufacturer),​
(3) only buy the critical part from the contract manufacturer and then buy an off-the-shelf part from a separate supplier, and then we put everything together and package/label from difference sources, or​
(4) just source the entire item from a contract manufacturer ready for sale.​

We are leaning toward choice #2, but are not sure whether that makes us a repackager or manufacturer. We have looked closely at the definitions of repackager and manufacturer and are not clear where the line is. CFR - Code of Federal Regulations Title 21

A "Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions."

A "Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers)."

Does someone know of case law or guidance on what defines a "finished device." We are trying to decide when we would be a repackager and when we would be a manufacturer (we know that you can be both, but we're trying to understand when you are only a manufacturer and not also a repackager). Are you a repackager if you buy two different bulk items made by contract manufacturers and put them in a package together without changing either item? For example, in theory, would you be a repackager or only a manufacturer if you produced a scalpel with disposable blades, but bough the scalpel finished, and bough off-the-shelf disposable blades and then put them in the same package? would the scalpel be a "finished device" without the blades, what if the blades are a common item that hospitals have around and it could be expected that they dont need our blades to use the scalpel? what if our blades have some advantage over others? Do we define whether something is a "finished device" ourselves by the fact that we sell it as finished?

Anyway, any guidance on this would be helpful.

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