United States Food and Drug Administration's 510(k) Pathway: Drawing Implications from the Approvals of Brachytherapy Devices.

Abstract

Introduction Innovations in cancer treatment coupled with an increasing number of cancer patients have led to the growth of brachytherapy devices. The objective of this study is to characterize the development and safety of brachytherapy devices marketed in the United States (US) over the last 15 years. Methods We reviewed records from a public US Food and Drug Administration (FDA) database detailing premarket approval of brachytherapy devices. All 510(k) submissions approved between January 1,