OpenMind Regulatory Resources
Type: Regulatory and Technical Documentation,
Keywords: Clinical protocols, IDE, Investigational Device Exemption, FDA, DBS, Deep-brain stimulation, QMS, Quality systems, Design control, RC+S, NeuroPace, RNS, Percept
An Open Science Framework webiste hosting shared regulatory and technical information relating to the use of bidirectional deep-brain stimulation devices in clinical research
This collection of documentation includes shared clinical protocols, IDE submission materials, FDA correspondence and meeting materials, file formats, QMS and design control background, and related reference material for groups designing and spearheading clinical studies utilizing advanced bidirectional DBS device technology.
* Clinical protocols for advanced deep-brain stimulation studies.
* IDE submission materials.
* FDA engagement materials.
* File format information.
* QMS/quality systems reference information.
* Development of a novel clinical protocol utilizing the Summit RC+S implantable device.
* Preparation of IDE submission materials for a bidirectional DBS device study.
* Preparation of meeting minutes for an FDA IDE pre-submission meeting.
* These tools help to inform the development of regulatory documentation and quality systems practices that are suited to sophisticated clinical studies utilizing advanced bidirectional DBS device technology.
* OpenMind tools and resources are most directly applicable to use cases involving bidirectional DBS device technology (e.g., Medtronic Summit RC+S and similar device systems).
* Borton et al. 2020, Developing Collaborative Platforms to Advance Neurotechnology and Its Translation. doi:10.1016/j.neuron.2020.10.001.
Phil Starr, Professor
David Borton, Asst. Professor
Tim Denison, Professor
Greg Worrell, Professor
Heather Dawes, Exec. Director
University of California, San Francisco; Brown University; University of Oxford; Mayo Clinic
TEAM / COLLABORATOR(S)
Phil Starr, Professor, UCSF; David Borton, Asst. Professor, Brown; Tim Denison, Professor, Oxford; Greg Worrell, Professor, Mayo Clinic; Heather Dawes, Exec. Director, UCSF