FDA is tackling cybersecurity threats head-on and expects industry to do the same. Earlier this month, FDA commissioner Scott Gottlieb, M.D., announced a series of developments designed to keep pace with evolving cybersecurity threats to medical devices. Industry should take note, as these developments detail the agency’s current expectations for companies preparing to combat future threats. As part of FDA’s effort to get in front of these issues before they happen, it launched its first ever Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook (the “Playbook”). FDA also announced two memoranda of understanding designed to improve information sharing about cybersecurity risks. Finally, just last week, FDA released an update to guidance from 2014 concerning premarket expectations for devices susceptible to cybersecurity threats.
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