P
Hello,
I am with a company that recently designed, developed, and submitted a 510(k) for approval for a Class II device. Once we obtain approval, we will exclusively license the design and the 510(k) to a manufacturer partner. That manufacturer will then sell that device to US distributors, with the US distributors name on it.
1) Is my company the spec developer? The regs say that a spec developer "Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment?s name by a contract manufacturer."
It seems the term "spec developer" is on the marketing side, after 510k is obtained.
2) Do you have to be a spec developer to file a 510(k)? Can you simply be an R&D firm that has the appropriate Design Control systems in place?
I am with a company that recently designed, developed, and submitted a 510(k) for approval for a Class II device. Once we obtain approval, we will exclusively license the design and the 510(k) to a manufacturer partner. That manufacturer will then sell that device to US distributors, with the US distributors name on it.
1) Is my company the spec developer? The regs say that a spec developer "Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment?s name by a contract manufacturer."
It seems the term "spec developer" is on the marketing side, after 510k is obtained.
2) Do you have to be a spec developer to file a 510(k)? Can you simply be an R&D firm that has the appropriate Design Control systems in place?