Combination Products Regulatory Video Series

A foundational overview of combination product types, regulatory complexity, and the FDA expectations that shape development and submission strategy.

How combination products are classified, how PMOA is determined, and how to approach FDA decision-making when jurisdiction is unclear.

When to seek FDA designation, how Pre-RFD and RFD submissions work, and the strategic considerations that can improve review outcomes.

An overview of NDA, BLA, PMA, 510(k), De Novo, and how cross-center FDA review affects submission strategy for combination products.

How to integrate FDA Part 820, ISO 13485, and drug or biologic GMP requirements into a unified and defensible quality framework.

Covers chemical, mechanical, biological, and clinical bridging approaches used to support compatibility, safety, and regulatory justification.

How usability engineering, instructions for use, and risk management work together to support safe real-world operation.

Complaint handling, safety surveillance, MDRs, CAPA processes, and key postmarket obligations in both U.S. and EU frameworks.

Covers software validation, cybersecurity risk management, connected systems, and alignment with key IEC and ISO expectations.

Real-world case studies exploring PMOA, bridging, human factors, and lifecycle lessons across several common combination product types.

How to use Master Files, authorization letters, and CMC modules to protect IP while supporting efficient FDA review.

Covers global harmonization, change control, postmarket evolution, and the long-term regulatory strategies needed to sustain compliance.