FDA partners with DHS, invites comment on draft update of medical-device security guidance

The Food and Drug Administration is seeking comment on an updated draft of its guidance for ensuring the cybersecurity for medical devices before they enter the market, and plans to collaborate with the Department of Homeland Security.

“Although FDA issued guidance addressing recommendations for device cybersecurity information in premarket submissions in 2014, the rapidly evolving landscape, and the increased understanding of the threats and their potential mitigations necessitates an updated approach,” reads a Federal Register notice posted today.

The...