Would a FDA-Listed/Registered "Manufacturer" aslo have to list themselves (also) as a contract manufacturer?

Also: I've got Spec Developers coming to us to bid on their designs (specs), but when we tell them we want to see a pro-forma contract to "spell-out" the relationship they tell us they've never written a contract (purchase order) to anyone else that's made the device for them. Does anyone have any terms and conditions, or other contract language, talking to what the spec developer wants done?

At a recent trip to an FMDIC-FDA workshop in Dallas I brought up this "weakness" and Dave Arvello (FDA) said that they see this all the time and that there must be a contract in-place spelling out what the spec developer wants/expects...

Would a FDA-Listed/Registered "Manufacturer" aslo have to list themselves (also) as a contract manufacturer?

Also: I've got Spec Developers coming to us to bid on their designs (specs), but when we tell them we want to see a pro-forma contract to "spell-out" the relationship they tell us they've never written a contract (purchase order) to anyone else that's made the device for them. Does anyone have any terms and conditions, or other contract language, talking to what the spec developer wants done?

At a recent trip to an FMDIC-FDA workshop in Dallas I brought up this "weakness" and Dave Arvello (FDA) said that they see this all the time and that there must be a contract in-place spelling out what the spec developer wants/expects...

I guess things depend on whether you are making components or entire assemblies.

Components are pretty straightforward - contract manufacturers keep traceability records.

For assemblies, regardless whether they are medical devices or plain widgets, you probably need to set your own terms as part of the bid.

At a minimum, I'd suggest:

quote for prototype - specify "not allowed for any use other than "sample" - not for further resale to intermediate or end users"
quote for non-sole source manufacture [i.e. if more than one supplier for an identical part, customer must agree to design or marking differentiation to avoid mixing your product with same product made by others.]
quote for sole source manufacture [include YOUR OWN statement of who shall have liability and ask for an indemnity from a financially responsible source as part of your risk analysis. The reason you want indemnity is that you may get FDA off your back, but not a plaintiff's lawyer if the "dirt" hits the fan.](ultimately, similar to FAA, downstream members of the supply chain must be aware of the FDA regulatory authority,which includes RIGHT of FDA to inspect manufacturing premises of those downstream suppliers.)

I like this article by Judith Andrews, Manager, Quality Assurance & Compliance Services
found at
http://www.mdci.com/pages/nwsltr_0411.html
which contains this excerpt [emphasis is mine]
A company may outsource any process involved in the commercialization of its product, including design, development, manufacturing, sterilization, packaging and distribution. A company can even contract with another firm to handle phone calls. However, the ultimate responsibility for the quality and safety of a medical device rests with the establishment that lists that product with the FDA.