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"Primary Mode Of Action" High On Combo Products Office Agenda

This article was originally published in The Silver Sheet

Executive Summary

FDA’s NASCENT OFFICE OF COMBINATION PRODUCTS is developing a definition of "primary mode of action" that will help ease the jurisdiction determination process for challenging device/drug/biologic combinations. Some stakeholders have suggested the agency take a risk-based approach to deciding which center has primary oversight of a combination product, while others argue that the overall function of a product is the key factor. OCP has issued revised procedures for tracking the progress of combination product applications and recently assumed full responsibility for the request for designation process. Deciding whether device quality system regs or drug GMPs should apply to a combination product continues to be a vexing question for manufacturers
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