I have a question relating to the development of a medical imaging devices. If this device was a camera with the assiociated software, used only for the diagnosis and observation of eye disease what guidelines should its development conform to? It has no thearapeutic benefit and it does require the administration of radioactive tracers.
Would it simply follow GMP and be considered a tool in development? Obviously patient consent is still require for data capture.
Any global responses appreciated. Particularly if you know of the Australian regulations.
Kind Regards
Yvonne
Perth, Western Australia