Product owner (A) contracts a “manufacturer” (B) (who is not a “contract manufacturer”) to perform the specification and development of their product. This same product owner (A) licenses his product to be sold by another FDA registered company (C). Does the product owner (A) need to be registered with the FDA as a “specification developer” even though they (A) contracted that duty to the “manufacturer” (B)?
Subcontracting specification developer duties
- Thread starter dscsbmp
- Start date
indubioush
Ah ha!
Which entity will appear on the label as the manufacturer of record? Who will own the design history file?
Assuming that the answer to @indubioush's question is "(A)" --
A will be (and should register as) a Specification Developer.
Someone will have to register and list the same device as a Contract Manufacturer - if not B then someone else.
If B is not the Contract Manufacturer, it's a supplier to A (apparently supplying D&D services).
The manufacturer (B) would appear on the label as the manufacturer of record. The manufacturer (B) would own the design history file.
To clarify, the manufacturer (B) would appear on the label as the manufacturer of record. The manufacturer (B) would own the design history file.
In that case (A) doesn't seem to have a regulatory role and doesn't need to register with the FDA. I guess (A)'s ownership is practised through (commercial) licensing to (B), or similar, right?
