Combination Products 26
- User Fees for Combination Products and Associated Waivers
- Essential Drug Delivery Outputs for Drug Delivery Devices and Combination Products (DRAFT)
- Technical Considerations for Physiologic Closed-Loop Control Medical Devices
- Human Factors Studies and Related Analyses for Combination Products
- Compliance Requirements for Ophthalmic Drug-Device Combination Products Following Genus Decision
- Premarket Review Pathways for Combination Products
- Obtaining FDA Feedback for Combination Products: Best Practices and Meeting Procedures
- Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
- Reliability Requirements for Emergency-Use Auto-Injectors (DRAFT)
- Bridging Strategies for Drug-Device and Biologic-Device Combination Products (DRAFT)
- Postmarketing Safety Reporting Requirements for Combination Products
- Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
- Medical Devices Used in Recovery, Isolation, and Delivery of Regenerative Medicine Advanced Therapies
- Selection of Package Type Terms and Discard Statements for Injectable Medical Products
- Heparin in Medical Devices and Combination Products: Testing, Labeling and Safety Requirements
- How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
- Classification of Products as Drugs or Devices: Interpretation and Determination Process
- Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions
- Technical Considerations for Pen, Jet, and Related Injectors Submitted in Drug and Biological Product Applications
- Glass Syringes: Testing and Performance Requirements for Connectivity with Needles and Other Devices (DRAFT)
- Postapproval Changes to Combination Products: Marketing Submission Requirements (DRAFT)
- How to Submit a Request for Designation (RFD) for Product Classification and FDA Center Assignment
- Adding Imaging Contrast Indications to Medical Devices Used with Approved Imaging Drugs
- Jurisdictional Determinations for HCT/P Processing Devices: CBER vs CDRH Assignment
- Early Development Considerations for Combination Products
- Dispute Resolution Process for Combination Product Review Timelines