FDA plans medical device software regulations
This article was originally published in Clinica
Executive Summary
The US FDA's Center for Devices & Radiological Health (CDRH) is preparing to write regulations for software associated with medical devices, reports Clinica's Washington correspondent, Duffy Miller. The agency began development of a software policy 11 years ago, but formal regulations have never been written. The CDRH has operated within the framework of a draft policy for the past seven years.