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 should provide when submitting a marketing application to FDA.”By comparison, FDA guidance issued in 2016 for postmarket medical device cybersecurity was much more detailed, she says.But now the recently released draft version updating FDA’s premarket medical device cybersecurity guidance “rolls in quite a lot of the details that was in the postmarket guidance, but frames it in the design and development phase,” she explains. “Together, the two are more cohesive.”

Source: https://www.healthcareinfosecurity.com/interviews/analysis-fdas-reworked-premarket-medical-device-guidance-i-4168