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!
As a contractor, is your establishment registered with FDA.
As the manufacturer, who has the 510k, how has his FDA inspection been so far.
Are you, the contractor based in the US of A.
Please note that FDA inspection is performed only by FDA personnel and is not subcontracted. So if you are out of US of A and your manufacturer and his FDA inspections are neat, you stand a low chance of a FDA routine inspection.
If your manufacturer has some 483’s and its resolution is directing to activities at your plant, and his responses are not effective, your chances of a FDA routine inspection is high. Be prepared for the same and you may have a call from a FDA inspector anytime to schedule an inspection.
If one or more of the “contractors” is a Contract Manufacturer, that is, what they ship is capable of performing at least one medical device function as shipped even though not yet integrated into a system, then that company must be a Registered Establishment and FDA will have no problem with them holding the system’s DHF and DMR or elements of them.
If however the “contractors” are not Registered Establishments, my expectation is that FDA is going to look askance at the responsible Manufacturer not having the DHF on-site. 21CFR 820.30(j) is clear, I think, in its requirement that the “manufacturer shall establish and maintain a DHF”. In my experience, FDA will not accept that a regulated party has arranged for someone else to handle one of the regulated party’s legal responsibilities when that second party is not itself subject to regulatory oversight.
To answer your original question: for a QSIT 1 (ordinary) inspection for which design control is an inspector-chosen inspection topic, it’s very likely that in the proposed circumstance the contractor will be inspected. There might be some delay in the subsequent inspection if it’s in a different region or a different country. For a for-cause or emergency inspection, contractor inspections are almost certain if FDA thinks that the role of the contractor might bear on the failure mode or other problem.
Just as an FYI, the FDA is in the process of revising the QSIT document and the draft of the new document is focused more on the supplier management for MD’s. As I understand it, the FDA is putting more risk on the supplier management since they have found more and more medical device companies are simply assembling and not actually manufacturing.