U.S. FDA's Regulation for Medical Combination Products

Medical combination products (MCPs) are the "fourth type" of medical products combining at least two different types: drugs, medical devices and/or biological products to produce therapeutic or diagnostic results better than those independently utilized. This type of product uses new and cutting-edge technology to work with different drug components, which is safer and more effective than single component. Their advantages have been well demonstrated in cancer, heart disease, neurological and metabolic diseases. With the advance of new technologies, such as artificial intelligence, nanotechnology, health information technology, molecular diagnostics, and cell and tissue engineering, more and more combination products have been marketed and have greatly benefited the patients. The U.S. FDA has gradually established a regulatory approach to medical combination products. Analyzing and understanding FDA's regulation for medical combination products will benefit China's pharmaceutical companies venturing into the development of medical combination products.