I'm working on a large, complex medical device that has some pretty serious hazards associated with it. The folks I'm working with are contractors to the company that's "manufacturing" the device (i.e., that holds the FDA clearance).
The manufacturer of the device is doing minimal design work, primarily writing high-level requirements for vendors. The vendors are developing and manufacturing complex subsystems that the manufacturer is integrating and then performing system test only. The manufacturer's position is that that detailed DHF, including testing and traceability to manufacturer requirements, will be held only by the contractors, and if/when the FDA inspects the manufacturer will point them to the contractors for any detailed design info.
So here's my question (after that long-winded set up): what is the possibility that FDA would visit these contractors and audit the DHF in the event of either a routine inspection of the manufacturer, or if the device has significant failures and FDA investigates?
Thanks in advance!
The manufacturer of the device is doing minimal design work, primarily writing high-level requirements for vendors. The vendors are developing and manufacturing complex subsystems that the manufacturer is integrating and then performing system test only. The manufacturer's position is that that detailed DHF, including testing and traceability to manufacturer requirements, will be held only by the contractors, and if/when the FDA inspects the manufacturer will point them to the contractors for any detailed design info.
So here's my question (after that long-winded set up): what is the possibility that FDA would visit these contractors and audit the DHF in the event of either a routine inspection of the manufacturer, or if the device has significant failures and FDA investigates?
Thanks in advance!