Yesterday the FDA issued final guidance entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," which includes recommendations for medical device manufacturers on cybersecurity management and information that should be included in a pre-market submission. The recommendations are intended to supplement previous FDA guidances, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," and "Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software."
In a related development, on October 21-22, 2014, the FDA is holding a public workshop on "Collaborative Approaches for Medical Device and Healthcare Cybersecurity." Through the workshop, FDA seeks to encourage collaboration among stakeholders, identify challenges, and discuss strategies and best practices for promoting medical device cybersecurity.
This article is presented for informational purposes only and is not intended to constitute legal advice.