The U.S. FDA’s 2022 draft cybersecurity guidance highlights the significant impact cybersecurity incidents have had on medical networks and devices throughout the world and includes updated approaches to medical product lifecycles.
If followed by medical device manufacturers, experts said that the Food and Drug Administration’s long-awaited draft cybersecurity guidance released on Thursday will go a long way towards improving device security and patient safety.
The FDA draft guidance, which replaces a 2018 document, lays out a total product lifecycle approach to cybersecurity with recommendations for how medical device manufacturers should address security in premarket submissions and in order to maintain their software-based products postmarket.
“This is the finished product from the 2018 outline. They really polished it and have done a much better job on this document. That’s not to say it’s without its faults. It has them but it’s a much better document,” said Chris Gates, director of product security at medical device engineering firm Velentium.
Read the full article at MedTech Dive.