Medical Device Databases and Resources
The FDA maintains several publicly accessible databases that may be of particular interest to sponsors and manufacturers of neurological devices including:
- Product classification
- 510k Premarket Notification database
- Premarket Approvals (PMA)
- Humanitarian Device Exemption (HDE)
- Post-Approval Studies (PAS) Database
- Recalls of Medical Devices
- MAUDE - Manufacturer and User Facility Device Experience
- FDA Recognized Consensus Standards
- FDA Guidance Documents
Clinicaltrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
Public Workshops
- Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions (HDEs) - December 18, 2017
- Webinar - De Novo Classification Process (Evaluation of Automatic Class III Designation) - November 21, 2017
- Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Premarket Approvals - July 26, 2017
- FDA Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway - Wednesday, March 22, 2017
- Webinar - Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies - Wednesday, September 14, 2016
- Public Workshop - Brain-Computer Interface Devices for Patients with Paralysis and Amputation, November 21, 2014 [ARCHIVED]
Additional Resources
- FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans
- Device Advice: Comprehensive Regulatory Assistance
- CDRH Learn