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IRB Ethical review of IDE and Other Medical Device Implantables and Integrated Mobile App,

pervasive sensing Medical Device Human Subjects Protections/IRB/Ethics Mobile Apps

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Browsing: IRB Ethical review of IDE and Other Medical Device Implantables and Integrated Mobile App,


Anonymous

posted

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.

Rubi Linares-Orozco

Posts: 34
posted

Will do my best to address your question without knowing the device specifics, capabilities, and interoperabilities, and connectivity to the mobile app/mobile device.

  1. For review of IDE's defer to FDA regulations.
  2. Depending on who or how the device is manufactured may need to look at the QC/ISO guidelines.
  3. As for devices linked to mobile devices , FDA provides guidance: https://www.fda.gov/medicaldevices/digitalhealth/mobilemedicalapplications/default.htm
  4. 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.
  5. 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.

Happy to discuss specifics offline- rlinares@ucsd.edu

Best,
Rubi