FDA’s Reworked Premarket Medical Device Guidance

The Food and Drug Administration's recently issued draft document updating its premarket medical device cybersecurity guidance originally issued in 2014 contains several important provisions, says regulatory attorney Yarmela Pavlovic."The 2014 guidance that FDA issued about premarket cybersecurity considerations was fairly sparse; it wasn't particularly detailed," Pavlovic notes in an interview with Information Security Media Group. "It was the first time FDA raised the issue of cybersecurity in a guidance, and it talked predominantly about the types of documents that companies...