
The U.S. Food and Drug Administration has released the following:
The U.S. Food and Drug Administration is critical to protecting and promoting public health. The products the FDA regulates are in every supermarket, pharmacy, and home across the U.S. Cybersecurity touches every facet of the FDA’s broad, complex responsibility. It’s one of our agency’s top priorities, and we take it seriously, particularly given today’s increased cybersecurity risks. During the pandemic, the FDA experienced a 457% increase in reconnaissance activities, denial of service, attempted exploitation, and other cyber incidents against IT infrastructure, that includes nearly 9.5 billion firewall and intrusion detection blocks on a monthly basis.
The FDA must enhance current cybersecurity defenses to address the ever-evolving threat landscape and protect the vital data supporting our regulatory decision-making. To achieve these new capabilities, the FDA is advancing an agency-wide approach to cybersecurity modernization under the direction of the Office of Digital Transformation, Office of Information Security (OIS). OIS provides near real-time cybersecurity capabilities and risk management methodologies to protect sensitive data and information systems and with a vision to provide a best-in-class, intelligence-driven cybersecurity program to enable the FDA’s public health mission.
Today we are introducing the Cybersecurity Modernization Action Plan (CMAP), the next phase of the FDA’s enterprise digital approach.

