Gastroenterology-Urology 16
- Non-Clinical Testing Recommendations for Weight Loss and Obesity Treatment Devices (DRAFT)
- Clinical Study Design and Benefit-Risk Considerations for Weight Loss Medical Devices (DRAFT)
- Clinical Studies for Medical Devices Treating Type 2 Diabetes Through Novel Therapeutic Approaches
- Clinical and Non-Clinical Testing for Medical Devices to Treat Benign Prostatic Hyperplasia (BPH)
- Conventional Foley Urinary Catheters - Performance Testing and Labeling Requirements
- Clinical Investigation Requirements for Prostate Tissue Ablation Systems
- Metal Expandable Biliary Stents and Associated Delivery Systems - Content and Testing Requirements for 510k Submissions
- Non-Clinical Testing Recommendations for Machine Perfusion Devices Used to Preserve Vascularized Human Organs for Transplant
- 510k Exemption for Unclassified Medical Devices in Selected Product Categories
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Mitigating Cross-Contamination Risks in Irrigation Valves and Accessories Used with Flexible Gastrointestinal Endoscopes
- Labeling Requirements for Permanent Hysteroscopic Tubal Implants for Female Sterilization
- 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
- Quality Assurance Guidelines for Hemodialysis Devices and Facilities