W
My particular question wrt the MDDS FR & the EU is regarding APM (active patient monitoring). There is *much* contraversy in the US regarding this exclusion from the MDDS, as it elevates systems used for APM into US FDA Class II (as opposed to an MDDS being a Class I device).
I've reviewed the material presented in this discussion, but have not yet come upon anything close to the FDA's interpretation of APM as it relates to an MDDS. It's clear that the EU is looking into MDDS-type devices, and, as a default one would be best advised to consider them Class I devices in the EU. However, if one were to overlay the APM interpretation, would it likely change this classification?
For the uninitiated, FDA's interpretation of APM is any device whose use may necesitate "imediate clinical action". Example: performing a remote tele-stroke assessment wherein the remote physician diagnoses the need for, and immediate administration of tPA (a blood clot-busting drug).
So if anyone has any addtional perspective on the APM issue within the MDDS as it relates to EU devices, this would be very helpful.
I've reviewed the material presented in this discussion, but have not yet come upon anything close to the FDA's interpretation of APM as it relates to an MDDS. It's clear that the EU is looking into MDDS-type devices, and, as a default one would be best advised to consider them Class I devices in the EU. However, if one were to overlay the APM interpretation, would it likely change this classification?
For the uninitiated, FDA's interpretation of APM is any device whose use may necesitate "imediate clinical action". Example: performing a remote tele-stroke assessment wherein the remote physician diagnoses the need for, and immediate administration of tPA (a blood clot-busting drug).
So if anyone has any addtional perspective on the APM issue within the MDDS as it relates to EU devices, this would be very helpful.
These posts have been split off of 2 threads and is now a "thread of it's own" to eliminate confusion.