Uneasy feeling for US industry as detail emerges of 510(k) overhaul
This article was originally published in RAJ Devices
Executive Summary
"These two preliminary reports recommend steps to strengthen and improve the 510(k) process and the use of science in decision making" and provide a "blueprint for smarter medical device oversight". That is the understated way in which Jeffrey Shuren, director of the US Food and Drug Administration's Center for Devices and Radiological Health, described what are likely to be the biggest changes to the regulation of low- to medium-risk medical devices for 34 years1.