Safety - Issues 13
- Testing and Labeling of Medical Devices for Magnetic Resonance (MR) Environment Safety and Compatibility
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Product Labeling Requirements for Laparoscopic Power Morcellators in Gynecologic Surgery
- Labeling Requirements for Ultrasonic Surgical Aspirator Devices - Contraindication for Uterine Fibroid Procedures
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Postmarket Management of Cybersecurity in Medical Devices
- Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions
- Public Notification of Medical Device Emerging Signals: New Safety Information and Adverse Events
- 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
- List of Device Types That Require Human Factors Data in Premarket Submissions (DRAFT)
- Applying Human Factors Engineering and Usability Engineering to Medical Devices