Investigational Device Exemption (IDE) 41
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Animal Testing for Medical Device Safety and Performance Evaluation
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Clinical Studies for Medical Devices Treating Type 2 Diabetes Through Novel Therapeutic Approaches
- Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Technical Considerations for Q-Submissions and IDE Applications
- Mouse Embryo Assay Testing for Assisted Reproduction Technology Devices
- Clinical Investigation Requirements for Prostate Tissue Ablation Systems
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Live Case Presentations During Investigational Device Clinical Trials
- Testing and Characterization of Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions
- Investigational In Vitro Diagnostic Devices Used in Therapeutic Product Clinical Trials (DRAFT)
- Technical Considerations for Additive Manufactured Medical Devices
- IDE Device Categorization for Medicare Coverage: Category A vs Category B Determination
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions
- Adaptive Designs for Medical Device Clinical Studies
- Assessment of Radiofrequency-Induced Heating in Multi-Configuration Passive Medical Devices for MR Conditional Labeling
- Clinical Trial Design and Regulatory Considerations for Nail Appearance and Onychomycosis Treatment Devices
- List of Device Types That Require Human Factors Data in Premarket Submissions (DRAFT)
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- IDE Clinical Investigation Decision Process and Requirements
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- Design Considerations for Medical Device Pivotal Clinical Studies
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Retinal Prostheses: Clinical, Non-Clinical, and Safety Recommendations for Electrical Stimulation Devices
- Financial Disclosure Requirements for Clinical Investigators
- The Content and Development of Premarket Submissions for Artificial Pancreas Device Systems
- Clinical Investigation of Nocturnal Home Hemodialysis Delivery Systems
- Total Artificial Disc Devices - Pre-clinical Testing and Clinical Trial Design Requirements
- Changes to Investigational Device Exemption (IDE) Protocols and When FDA Approval is Required
- Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures
- Organ Preservation Solutions for Transplantation - Testing and Development Requirements
- Promotion and Recruitment for Investigational Medical Devices
- IDE Content Requirements for Refractive Surgery Laser Clinical Investigations
- Format and Content of IDE Progress Reports