Browsing: IRB Ethical review of IDE and Other Medical Device Implantables and Integrated Mobile App,
I am looking for some resources/shared experience in reviewing IDEs that consist of implantabes that are read with a mobile app. As a human subjects protections reviewer/IRB review- what are the priroities and issues that became evident to you in this type of device review. What additonal consent language forms did you use, what types of policies/SOPS came of your experience? Any and all information/opinion is welcome.
Will do my best to address your question without knowing the device specifics, capabilities, and interoperabilities, and connectivity to the mobile app/mobile device.
For review of IDE's defer to FDA regulations.
Depending on who or how the device is manufactured may need to look at the QC/ISO guidelines.
Depending on what data flows from the implantable to the application, you may need to look at the Privacy and Security aspects as well- in regards to protecting subject confidentiality.
If the data flows through international servers, you may also need to consider GDPR rules and regulations.
A great starting point is the FDA regulations, given you mentioned it was an implantable, typically are Signigicant Risk devices so they carry more regulatory requirements than a non-significant risk device.