Hi there,
I've been trying to find some clear FDA guidance on requirements around devices to be used for verification and validation testing but I still seem to be at somewhat of a loss, so I hope you helpful folks can shine some light on it for me...
We are currently starting formal verification of a ventilator device and we will be using devices that have been manufactured in a "Verified" manufacturing process (IQ, OQ) but not a validated process (PQ). I have read in 21 CFR Part 820: 820.30(g) that design validation should be run on "initial production units, lots or batches or their equivalents". Does this mean that devices used for validation need to come off a validated (PQ) manufacturing process?
Secondly, I am also curious about making changes to production equivalent devices during verification testing:
I've been trying to find some clear FDA guidance on requirements around devices to be used for verification and validation testing but I still seem to be at somewhat of a loss, so I hope you helpful folks can shine some light on it for me...
We are currently starting formal verification of a ventilator device and we will be using devices that have been manufactured in a "Verified" manufacturing process (IQ, OQ) but not a validated process (PQ). I have read in 21 CFR Part 820: 820.30(g) that design validation should be run on "initial production units, lots or batches or their equivalents". Does this mean that devices used for validation need to come off a validated (PQ) manufacturing process?
- So, would it be deemed acceptable to run validation with devices coming from an non-validated process?
- And how about summative Human Factors studies? should that also be run with devices from a PQ'ed process?
Secondly, I am also curious about making changes to production equivalent devices during verification testing:
- If we find the need for, say, a redesign of a mechanical component to meet a design requirement and we need to upgrade some (or all) devices under test with that change, can we do that in our test lab or do we need to send devices back to the CMO to have them rebuild the devices in a verified mfg environment?