This session will discuss FDA’s current thinking and expectations on addressing cybersecurity risks and also provide industry perspectives on the technical and regulatory cybersecurity considerations for combination products.

As combination products become increasingly integrated with device technologies that are connected to the internet, hospital networks, and mobile applications, they can become more vulnerable to cybersecurity threats. A 2022 report by the FBI indicated that 53% of connected medical devices had critical cybersecurity vulnerabilities. In addition, according to the FDA, cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. To address these emerging cybersecurity threats, the recently passed Consolidated Appropriations Act of 2023 includes several cybersecurity provisions, including new premarket requirements for manufacturers of cyber devices and related systems.