ABSTRACT
There are a variety of terminologies, definitions, and interpretations applied across international jurisdictions with respect to the combined use of medical products and technologies. In each case, regardless of the differences, the evolving regulatory and quality system landscape intends to ensure that, above and beyond the safety and efficacy of the drugs, devices and/or biological products alone, their combined use likewise meets quality, safety and efficacy expectations, ultimately to promote and protect public health. The successful combination product sponsor must be aware of the gamut of interpretations to successfully navigate the regulatory expectations and processes among jurisdictions. This chapter reviews key terminology, definitions, classifications for combination products, as well as examples of what is – and is not- considered a combination product from jurisdiction to jurisdiction.
