a note on the fda perspective on combination therapeutic and medical devices
This is a PDF document titled "A Note on the FDA Perspective on Combination Therapeutic and Medical Devices" created in September 2025. It provides a detailed regulatory overview of combination products that include therapeutic and medical device components, discussing FDA definitions, regulatory pathways, approval processes, human factors engineering requirements, and market exclusivity considerations. The document is authored by Harvard Business School faculty and experts and serves as an educational or reference material on FDA regulatory perspectives for combination therapeutic and diagnostic products.
Questions this document answers
The federal agency responsible for regulating food, drugs, medical devices, and biological products in the U.S., ensuring safety and efficacy before market release.
The single most important therapeutic action of a combination product contributing to its intended effects, guiding the regulatory pathway.
FDA requirements for user-centered testing, risk mitigation, and validation for combination products involving medical devices.
Protection periods post-approval that prevent market competition, varying for biologic and drug-based products.
Includes Single Entity Products, Co-packaged Products, Cross-labeled Products, each with distinct characteristics and development considerations.