Pediatric Product Development 21
- Long-Term Neurodevelopmental Safety Evaluation of Medical Products Used in Neonates
- User Fees for Combination Products and Associated Waivers
- Essential Drug Delivery Outputs for Drug Delivery Devices and Combination Products (DRAFT)
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Process for Research Involving Children that Requires FDA and OHRP Review under 21 CFR 50.54 and 45 CFR 46.407 (DRAFT)
- Ethical Considerations for Clinical Investigations of Medical Products in Children (DRAFT)
- Live Case Presentations During Investigational Device Clinical Trials
- Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Leveraging Existing Clinical Data for Pediatric Medical Device Indications
- Meetings with the Office of Orphan Products Development: Procedures and Best Practices
- Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A
- Premarket Assessment of Medical Devices for Pediatric Use
- Pulse Oximeters - Performance Testing and Safety Requirements for SpO2 and Pulse Rate Measurement Devices
- In Vitro Diagnostic Devices for Detection and Differentiation of Influenza Viruses - Performance Testing and Validation Requirements
- Clinical Investigation of Medical Devices for Treatment of Urinary Incontinence
- Process for Clinical Investigations Involving Children Requiring Additional Safeguards
- Pediatric Expertise for Advisory Panels Reviewing Medical Device Submissions
- Preparation of IDE Applications for Spinal Systems: Pedicle Screws, Intervertebral Body Fusion, Vertebral Body Replacement, and Disc Replacement Devices
- General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations