Re: Definiton of contract manufacturer
It might be worth noting that, within FDA jurisdiction, "private label" sometimes has nearly the opposite meaning of how it's been used in this thread.
When a Manufacturer labels their product to be sold under the name of a distributor, that's frequently called "private label manufacturing". The Manufacturer remains fully responsible for the product's regulatory stance.
The distinction in usage depends on whether the customer is an OEM or a distributor. Wes's description is of dealing with the former type of customer; my employer mostly deals with the latter type.
Sometimes the distributor is quite particular about what they want to buy; this might be called "providing specifications", except that most distributors don't have a regulatory system and aren't able to take responsibility for products...so the Manufacturer has to handle it. It's just how the marketplace works. In that respect, the FDA's role definitions are sometimes unrealistic.
As to Wes's comments on contract manufacturer's quality systems, note that the FDA doesn't require a contract manufacturer to be a registered Device Establishment, or even have a quality system except in special circumstances. That's not to say that, as Wes suggests, customers won't prefer a contract manufacturer that has their act together. Whether a contract manufacturer is registered and has a QMS also isn't relevant to the FDA's ability to come visiting, if you do work for a device marketer that gets into trouble and the evidence-trail leads to your door.