Diving into FDA’s Cybersecurity Expectations

In April, FDA released the latest draft of requirements for cybersecurity in premarket submissions.

Christopher Gates, director of product security at Velentium, discussed the new medical device cybersecurity laws and regulatory requirements and review the new manufacturer's activities expected by FDA during a panel at BioMeDevice Silicon Valley. 

These activities include the expected 38 cybersecurity deliverables.

Most importantly, Gates spoke about how to add cybersecurity processes to a product’s development lifecycle that will satisfy FDA and secure the medical device system without generating massive cost burdens or development delays.