FDA Releases Draft Guidance For Medical Device Cybersecurity

The new guidelines address post-market management of cybersecurity vulnerabilities.

New draft guidance from the Food and Drug Administration addresses steps manufacturers must follow to ensure their medical devices are protected against cyberattacks. According to the guidelines, device makers must not only establish design inputs related to cybersecurity, they must also address post-market threats that could emerge after the product has been marketed.

“All medical devices that use software and are connected to hospital and health care organizations’ networks have vulnerabilities — some we can proactively protect against, while others require vigilant monitoring and timely remediation,” Suzanne Schwartz, M.D., M.B.A., associate director for science and strategic partnerships and acting director of emergency preparedness/operations and medical countermeasures in the FDA’s Center for Devices and Radiological Health, explained in a statement. For the full article click here 

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