In a letterto commissioner Robert Califf, MD and CDRH director Jeffrey Shuren, MD, JD, DeGette and Brooks said: “The need for effective cybersecurity of medical devices has become more important with the increasing use of wireless, internet- and network-connected devices.
“Up to 15 million medical devices in circulation, ranging from monitors and infusion pumps to ventilators and radiological technologies, are integrated into the nation’s digitized healthcare network, creating possible avenues for cyber-attacks. As cyber threats continue to evolve at a rapid pace, FDA must work to prevent emerging threats, mitigate existing vulnerabilities, and assess the strength of a device’s cyber resilience in both pre-market and post-market contexts.”
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