robert.beck
Involved In Discussions
we have a 510(k) cleared class 2 device that is being in a drug study. the device is a monitoring device and is used to collect patient physiological response to medication administration. someone is telling me on some unknown authority that the devices must be labeled investigational. is there a regulatory or guidance document that requires this? where is this coming from.
the device is also CE marked and I'm getting the same requirement when it is used in a clinical trial in the EU, even though the device itself is not the subject of the trial. it is just a data collection tool.
the device is also CE marked and I'm getting the same requirement when it is used in a clinical trial in the EU, even though the device itself is not the subject of the trial. it is just a data collection tool.