ABSTRACT
The lead center is based on which constituent part provides the primary mode of action for the combination product. While the FDA application type is aligned with the lead center, the combination product manufacturer can choose which base cGMP system to utilize for the combination product streamline approach, regardless of lead center or application type. Combination products have been in existence and inspected by US FDA investigators for over two decades even before the Office of Combination Products was officially created on December 24, 2002, following the publication of the Medical Device User Fee and Modernization Act of 2002. Prior to 2002, staff within the US FDA Office of the Commissioner assigned to combination products would assist with combination product classifications, designations, and coordination between different FDA centers, and coordination between the centers and the FDA Office of Regulatory Affairs.
