- Develop and submit IDE Pre-Sub to the FDA Center for Devices and Radiological Health (CDRH) Division of Health Technology 5A (Neurological, Neurointerventional, and Neurodiagnostics) to obtain feedback on study design, review issues, and applicable oversight of the implantable device to inform a successful IDE submission.
- Determine the UK regulatory requirements for the clinical trial, including UK Medicines and Healthcare products Regulatory Agency (MHRA) and their local ethics board.
- Participate in research ethics consultations and early discussions with IRB
- Using findings from this regulatory discovery phase, create a comprehensive regulatory plan of the study design and timeline for 1-2 human subjects. This will include the plan for initial regulatory approvals, and planned periods to allow for device modification and subsequent regulatory review and approval. This report will be provided to TRISH.
- Develop and submit full IDE application to FDA.
Principal Investigator(s)
Award Info
Translational Research Institute (TRI)