When does a Distributor become a Specification Developer?

#1
I've done some searching but can't find anything definitive so I thought I'd throw this out there: When does a Distributor become a Specification Developer?

I have a few clients that are Manufacturers of Class II devices, some 510(k) exempt and some not. Many different companies engage these Manufacturers on a private-label/Distributor basis for various products. As the Manufacturers, obviously my clients maintain the DHF and DMR for the devices. They might have 5-10 companies all buying nearly identical devices.

As you can expect, the Distributor customers often want slight tweaks to the design, sometimes a different material but generally the changes are mostly aesthetic (i.e., there's no affect on the required V/V for the design). The Manufacturers handle these deviations by essentially creating new design documentation as though they themselves created the design, sometimes pursuing a new 510(k) if necessary, and carrying on with the customer as a Distributor. I view this as a service that they offer their customers, assuming responsibility in this way.

Is there any reason my Manufacturer clients cannot assume full regulatory responsibility for Distributors in this manner? Is there any precedence or history of FDA saying to a Distributor, "Wait a second, they made this design specifically for you, you're not a Distributor you're a Specification Developer!" Or, conversely, auditing a Manufacturer's design documentation and in turn tracking down a Distributor and saying the same?

It's worth nothing here that the Manufacturers have Quality Agreements in place with their customers (Distributors) saying that as Manufacturers they will be fully responsible for nearly everything and that the customer is just a Distributor. It appears, based upon what I've read here in other posts, that so long as the labeling is compliant per 801.1(c) ("Distributed By"/"Manufactured For") and the Manufacturers are willing to assume full responsibility in a signed agreement, this should be fine. Based upon my understanding, the difference between a Distributor and Specification Developer is mostly one of Registration/Listing, Contract/Agreement, and if a 510(k) is required then also of 510(k) ownership.

Any insight or experience would be greatly appreciated!
 
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#2
It's worth nothing here that the Manufacturers have Quality Agreements in place with their customers (Distributors) saying that as Manufacturers they will be fully responsible for nearly everything and that the customer is just a Distributor. It appears, based upon what I've read here in other posts, that so long as the labeling is compliant per 801.1(c) ("Distributed By"/"Manufactured For") and the Manufacturers are willing to assume full responsibility in a signed agreement, this should be fine. Based upon my understanding, the difference between a Distributor and Specification Developer is mostly one of Registration/Listing, Contract/Agreement, and if a 510(k) is required then also of 510(k) ownership.
I generally agree with your view. The only point I slightly deviate is 510(k) ownership, that IMO should not be taken as an indicator since it may be transferred and there are many possible different scenarios.
In my view the main difference between a Spec Dev and a Distributor is the formal taking of regulatory responsibility. In the case you described the allocation of regulatory responsibility seems clear so it's a relatively simple call.
I think that what the FDA cares about most is that responsibility is taken in full; they won't be too concerned by who's taking it (under-resourced to chase low risk issues).
 
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