Medical Devices and Combination Products: General Regulatory Framework

Abstract

During the last two decades, an unprecedented growth in innovative technologies has led to the development of state-ofthe- art medical devices in the healthcare sector. The regulatory aspects of medical devices are complex with variety of categories, ranging from a thermometer to diagnostic apparatuses, stents and catheters, syringes and hypodermic needles, blood transfusion and intravenous equipment, to robotically-assisted surgical devices (RASDs). In addition, there are subsets of medical devices such as in vitro diagnostics (IVD) or companion diagnostics (CDx) that provides information for the safe and effective use of a specific therapeutic agent. A natural extension of medical devices also includes combination products which could include two or more products from different categories such as medical device and/or a drug and/ or a biologic or possibly all three. In this manuscript, the current general regulatory framework for medical devices and combination products involving a medical device will be discussed.