EP 26: Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation
EPISODE 26: Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations
#BCI #Paralysis #BrainComputerInterface #AmputationPatients
In this video, medical device regulatory affairs expert and former FDA staffer David Pudwill will cover:
1. Background on Brain-Computer Interface (BCI) devices and FDA involvement in the space.
2. FDA Recommendations for Pre-Submissions and Investigational Device Exemption (IDE) studies.
3. FDA’s Perspective on Clinical Study Considerations for BCI device studies.
The referenced documents:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/implanted-brain-computer-interface-bci-devices-patients-paralysis-or-amputation-non-clinical-testing
https://www.fda.gov/media/120362/download
Music: Optimistic / Inspirational by Mixaund, https://mixaund.bandcamp.com
Music promoted by https://www.free-stock-music.com
MAKE SURE TO SUBSCRIBE to receive updates on when new "FDA Guidance Review" episodes are posted. We also look forward to your feedback, comments, and suggestions for topics that you would like David to cover in future episodes, so that this channel provides maximum benefit to you and your team.
Visit https://mrregulatory.com/ to get updates on new video releases, David Pudwill's upcoming speaking engagements in the medtech regulatory affairs space, and more!
Follow David on LinkedIn:
https://www.linkedin.com/in/david-pudwill/
Follow @RegMastery on Twitter:
https://twitter.com/RegMastery
E-mail: david@mrregulatory.com
EPISODE 26: Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations
#BCI #Paralysis #BrainComputerInterface #AmputationPatients
In this video, medical device regulatory affairs expert and former FDA staffer David Pudwill will cover:
1. Background on Brain-Computer Interface (BCI) devices and FDA involvement in the space.
2. FDA Recommendations for Pre-Submissions and Investigational Device Exemption (IDE) studies.
3. FDA’s Perspective on Clinical Study Considerations for BCI device studies.
The referenced documents:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/implanted-brain-computer-interface-bci-devices-patients-paralysis-or-amputation-non-clinical-testing
https://www.fda.gov/media/120362/download
Music: Optimistic / Inspirational by Mixaund, https://mixaund.bandcamp.com
Music promoted by https://www.free-stock-music.com
MAKE SURE TO SUBSCRIBE to receive updates on when new “FDA Guidance Review” episodes are posted. We also look forward to your feedback, comments, and suggestions for topics that you would like David to cover in future episodes, so that this channel provides maximum benefit to you and your team.
Visit https://mrregulatory.com/ to get updates on new video releases, David Pudwill’s upcoming speaking engagements in the medtech regulatory affairs space, and more!
Follow David on LinkedIn:
https://www.linkedin.com/in/david-pudwill/
Follow @RegMastery on Twitter:
https://twitter.com/RegMastery
E-mail: david@mrregulatory.com
