FDA Medical Device Guidance
Last week the US Food and Drug Administration (FDA) finally released a couple of important documents. The first being their guidance on using radio frequency wireless technology in medical devices (replacing a draft from January 3,2007), and a second being their new (draft) guidance on premarket submission for management of cybersecurity in medical devices. The wireless technology guidance document seeks to address many of the risks and vulnerabilities that have been disclosed in medical devices (embedded or otherwise) in recent years – in particular those with embedded RF wireless functionality…