Introduction to Combination Products: Drug-Device and Biologic-Device Regulatory Pathways The convergence of digital health technologies with traditional medical devices, drugs, and biologics has become increasingly prevalent. Combination products—defined by the FDA as therapeutic and diagnostic goods that combine a drug with a device, or device with a biologic—present distinct regulatory challenges and opportunities. This tutorial intends to guide professionals in the regulatory affairs, quality assurance, and clinical sectors through the intricate landscape of combination product regulations set forth by the U.S. Food and Drug Administration (FDA), focusing specifically on the pathways for authorization. Regulatory frameworks, including the guidance on combination…

Risk Management and FMEA for Drug and Device Failure Modes Risk Management and FMEA that Spans Both Drug and Device Failure Modes Introduction to Combination Products Regulatory Pathways Combination products, which integrate drugs, devices, and biological products, present unique regulatory challenges for professionals in the fields of quality assurance (QA), regulatory affairs (RA), and clinical development. The United States Food and Drug Administration (FDA) categorizes these products based on their primary mode of action (PMOA)—the main intended purpose of the combination product. Understanding how to manage risks associated with both drugs and devices is crucial for compliance with FDA regulations….

Governance for Cross-Functional Decision Making on Combination Development In the increasingly complex landscape of combination products—comprising both drug-device and biologic-device regulatory pathways—effective governance is critical. This article provides a comprehensive step-by-step tutorial on governance structures, regulatory considerations, and decision-making processes that facilitate successful development and compliance with U.S. FDA regulations. It aims to equip regulatory affairs, quality assurance, and clinical professionals with the essential knowledge needed to navigate the intricacies surrounding combination products. Understanding Combination Products Combination products comprise two or more regulated components—typically a drug and a device or a biologic and a device—packaged together or presented as a…

CMC, Device and Clinical Documentation Needed in Combination Submissions Combination products, which integrate drug, device, and biologic components, present unique regulatory challenges for manufacturers. Understanding the necessary Chemistry, Manufacturing, and Controls (CMC), device, and clinical documentation is crucial for successful submissions to the U.S. Food and Drug Administration (FDA). This tutorial provides a comprehensive step-by-step guide to navigate the regulatory pathways for combination products, focusing on the critical elements required for compliance. Understanding Combination Products Combination products are defined by the FDA as therapeutic and diagnostic products that combine drugs, devices, and/or biological products. The classification of a combination product…

Lifecycle Management of Combination Products and Constituent Changes Lifecycle Management of Combination Products and Constituent Changes The management of combination products that include both drug and device components is essential for ensuring compliance with regulatory pathways defined by the United States Food and Drug Administration (FDA). This tutorial provides a step-by-step guide for Regulatory, Quality, Clinical, and RA/QA professionals in the effective lifecycle management of these complex products, focusing on the interrelationship between constituent changes, primary mode of action, and the required coordination between the Office of Pharmaceutical Quality (OPQ) and the Center for Devices and Radiological Health (CDRH). Understanding…