The regulatory pathway for using RC+S is complex and the steps involved are best discussed with Robert Raike from Medtronic. robert.s.raike@medtronic.com It is always a good idea to have a [presumbission][1] conversation with the FDA prior to IDE sumbission, and a contract with Medtronic is also required. In order to help existing users that wish to start their own protocols using RC+S we will be sharing approved IDE's sumbitted to the FDA. Feel free to modify and use for your purposes. Our only request is that you share back your approved IDE once it is accepted in this forum. **UCSF IDE Files:** - [Final IDE][2] - [Risk analysis section][3] - [Presub meeting minutes][4] - [FDA feedback][5] - [Informed Consent Form][6] [1]: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf [2]: https://osf.io/cmndq/ [3]: https://osf.io/b7u2e/ [4]: https://osf.io/uc8ya/ [5]: https://osf.io/sdqgn/ [6]: https://osf.io/xmd7u/