Re: Remanufacturer vs. Refubisher under FDA QSR
I'm coming in a bit late on this since it was posted about 3 months ago, but in case it helps clear things up, as long as you don't take ownership of a device and are only repairing it as a service, then you are largely unregulated from a cGMP standpoint.
That doesn't necessarily preclude the FDA from issuing a warning letter for not following the cGMPs (as it has been known to happen) but FDA revoked CPG 7124.28 largely because it was inconsistent with the QSRs. Subsequent to this revocation, a different CPG was issued. CPG 7382.845 (Issued June 15, 2006) states that "Third party refurbishers, reconditioners, ... are currently not subject to the requirements of the Quality System Regulation"
If you are refurbishing and re-selling the product, however, you should definitely follow the advice already given.