Please find the first DRAFT Guidance document distributed for comments only that came out yesterday June 13, 2013. "Content of Premarket Submissions for Management of CyberSecurity in Medical Devices. Please also refer to www.seclingua.com as this DRAFT Guidance validates the technology behind www.seclingua.com
This guidance has been developed by the FDA to assist industry by identifying issues related to cybersecurity that manufactures should consider in preparing premarket submissions for medical devices. The need for more effective cybersecurity to assure medical device functionality has become more important with the increasing use of wireless, internet, network connected devices, and the frequent electronic exchange of medical device related health information.
