Premarket Approval (PMA) 46
- 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
- Developing and Responding to Medical Device Marketing Application Deficiencies
- FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
- Patient Labeling for Laser-Assisted In Situ Keratomileusis (LASIK) Devices (DRAFT)
- Safer Technologies Program for Medical Devices and Device-Led Combination Products with Enhanced Safety Benefits
- Mouse Embryo Assay Testing for Assisted Reproduction Technology Devices
- Classification and Special Controls for Posterior Cervical Screw Systems
- Appeals Process and Documentation Requirements for Significant Medical Device Submission Decisions
- Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
- Annual Reports for PMA-Approved Medical Devices: Content, Format and Submission Requirements
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- Labeling for Intravascular Devices with Lubricious Coatings
- Humanitarian Device Exemption (HDE) Program: Operational Requirements and Benefit-Risk Assessment
- Benefit-Risk Determinations for Medical Device Premarket Review
- Benefit-Risk Assessment with Uncertainty in Medical Device Premarket Submissions
- Testing and Characterization of Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- Heparin in Medical Devices and Combination Products: Testing, Labeling and Safety Requirements
- Technical Considerations for Additive Manufactured Medical Devices
- Establishing Performance Characteristics for Human Papillomavirus (HPV) Detection In Vitro Diagnostic Devices
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- 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
- Clinical Trial Considerations for Neurological Devices Intended to Slow, Stop, or Reverse Disease Progression
- Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions
- Adaptive Designs for Medical Device Clinical Studies
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (DRAFT)
- Leveraging Existing Clinical Data for Pediatric Medical Device Indications
- 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)
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Testing and Clinical Requirements
- Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- The Content and Development of Premarket Submissions for Artificial Pancreas Device Systems
- Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
- Quality System Information Requirements for Premarket Submissions
- Day-100 Meetings for PMA Applications: Procedures and Implementation