HUD/HDE 17
- Ethylene Oxide Sterilization Facility Changes for Class III Medical Devices During EPA Emissions Standards Transition
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Manufacturing and Supply Chain Changes for PMA and HDE Devices During Public Health Emergency
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Animal Testing for Medical Device Safety and Performance Evaluation
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- Humanitarian Device Exemption (HDE) Program: Operational Requirements and Benefit-Risk Assessment
- Benefit-Risk Assessment with Uncertainty in Medical Device Premarket Submissions
- Heparin in Medical Devices and Combination Products: Testing, Labeling and Safety Requirements
- Technical Considerations for Additive Manufactured Medical Devices
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions
- Clinical Trial Considerations for Neurological Devices Intended to Slow, Stop, or Reverse Disease Progression
- Adaptive Designs for Medical Device Clinical Studies
- Leveraging Existing Clinical Data for Pediatric Medical Device Indications
- Clinical Trial Design and Regulatory Considerations for Nail Appearance and Onychomycosis Treatment Devices