Mark Kramer answers 5 questions on combination products and the regulatory hurdles manufacturers can face.
1. What is a combination product?
A combination product is a combination of different types of regulated products, i.e., a drug and a device, a drug and a biologic, a device and a biologic, or a combination of a drug, device and biologic. FDA recognizes 3 types of combination products, where the components are (1) physically/chemically combined into a single entity (like a drug-coated catheter), (2) packaged together, or (3) separate products brought together through their labeling (“cross labeling”). The US is unique in recognizing cross labeled components as combination products, and these sometimes raise challenging regulatory issues.