Neurological 12
- Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Technical Considerations for Q-Submissions and IDE Applications
- Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes
- Labeling for Intravascular Devices with Lubricious Coatings
- Coronary, Peripheral, and Neurovascular Guidewires - Performance Testing and Documentation Requirements
- 510k Exemption for Unclassified Medical Devices in Selected Product Categories
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Design Considerations and Recommendations for Interoperable Medical Devices
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- Clinical Trial Considerations for Neurological Devices Intended to Slow, Stop, or Reverse Disease Progression
- Assessment of Radiofrequency-Induced Heating in Multi-Configuration Passive Medical Devices for MR Conditional Labeling
- Applying Human Factors Engineering and Usability Engineering to Medical Devices