TY  - CHAP
AB  - Abstract This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.
VL  - 26
SN  - 978-1-78635-238-5, 978-1-78635-237-8/1048-4736
DO  - 10.1108/S1048-473620160000026007
UR  - https://doi.org/10.1108/S1048-473620160000026007
AU  - Kitchens William H.
PY  - 2016
Y1  - 2016/01/01
TI  - FDA Regulatory Approval Process for Medical Products
T2  - Technological Innovation: Generating Economic Results
T3  - Advances in the Study of Entrepreneurship, Innovation and Economic Growth
PB  - Emerald Group Publishing Limited
SP  - 201
EP  - 229
Y2  - 2024/04/20
ER  -