Regulatory aspects of medical devices and biomaterials

Regulatory aspects are an integral part of a medical device development activity for potential commercialization. All across the globe, a medical device needs approval before application concerning the human body. Unfortunately, this important fact is not always appreciated. This chapter attempts to provide some knowledge of the approval process with an emphasis on regulatory aspects of orthopedic devices in the United States. The motivation behind writing this chapter is to create a benchmark for comparison and access to a vast amount of data available with the US Food and Drug Administration (FDA). This chapter distinguishes between classes of devices and protocols involved in getting approvals for devices, starting off with important nomenclature. Next, various steps in the approval process are elucidated. Finally, a comparison is made between the US and EU approval processes.