W
I thought I seen this asked before but now I can't find it anymore so I will just ask again.
"exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile."
If the label on the device has "Gamma Irradiated" printed on it is that representing sterile? And how about for MDD? Would that also constitute that the device is sterile?
"exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile."
If the label on the device has "Gamma Irradiated" printed on it is that representing sterile? And how about for MDD? Would that also constitute that the device is sterile?